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Dose Ranging Study of GSK1265744 Plus Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus-1 (HIV-1) Virologic Suppression Followed by Virologic Suppression Maintenance by GSK1265744 Plus Rilpivirine

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ClinicalTrials.gov Identifier: NCT01641809
Recruitment Status : Completed
First Posted : July 17, 2012
Results First Posted : January 30, 2020
Last Update Posted : January 30, 2020
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Infection, Human Immunodeficiency Virus
HIV Infections
Interventions Drug: GSK1265744 10 mg
Drug: GSK1265744 30 mg
Drug: GSK1265744 60 mg
Drug: Efavirenz 600 mg
Drug: Rilpivirine 25 mg
Drug: Placebo
Drug: Abacavir/Lamivudine (ABC/3TC) or Tenofovir/Emtricitabine (TDF/FTC)
Enrollment 244
Recruitment Details This was a multicenter, two part study in human immunodeficiency virus-1 (HIV-1) infected antiretroviral therapy (ART) naïve adult participants conducted across 48 sites in the United States (US) and Canada.
Pre-assignment Details A total of 324 participants were screened, of which 80 failed screening and 244 participants were randomized to one of the four treatment arms in a ratio of 1:1:1:1. Of the 244 randomized participants, only 243 received atleast one dose of study treatment and comprised the Intent-to-Treat-Exposed (ITT-E) Population.
Arm/Group Title GSK1265744 10 mg GSK1265744 30 mg GSK1265744 60 mg Efavirenz 600 mg
Hide Arm/Group Description Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Period Title: Induction Phase (Day 1 to Week 24)
Started 60 60 61 62
Completed 52 53 55 47
Not Completed 8 7 6 15
Reason Not Completed
Withdrawal by Subject             1             1             0             1
Physician Decision             0             1             0             1
Lost to Follow-up             1             2             0             3
Protocol Violation             2             1             1             0
Lack of Efficacy             4             1             2             3
Adverse Event             0             1             3             7
Period Title: Maintenance Phase (Week 24 to Week 96)
Started 52 53 55 47
Completed 46 48 52 41
Not Completed 6 5 3 6
Reason Not Completed
Withdrawal by Subject             2             3             1             0
Physician Decision             0             1             0             0
Lost to Follow-up             2             0             1             2
Lack of Efficacy             1             1             0             2
Adverse Event             1             0             1             2
Period Title: Open-label (Week 96 to Week 324)
Started 46 47 [1] 51 [1] 0 [2]
Completed 30 35 43 0
Not Completed 16 12 8 0
Reason Not Completed
Withdrawal by Subject             2             3             1             0
Physician Decision             0             1             1             0
Lost to Follow-up             5             4             5             0
Site closed             1             0             0             0
Protocol Violation             1             1             0             0
Lack of Efficacy             4             1             0             0
Adverse Event             3             2             1             0
[1]
1 participant completed study as per protocol at Week 96 and opted to not enter open-label phase
[2]
Participants completed study at Week 96 and did not enter open-label phase
Arm/Group Title GSK1265744 10 mg GSK1265744 30 mg GSK1265744 60 mg Efavirenz 600 mg Total
Hide Arm/Group Description Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. Total of all reporting groups
Overall Number of Baseline Participants 60 60 61 62 243
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 60 participants 61 participants 62 participants 243 participants
34.0  (9.91) 34.4  (10.24) 36.2  (10.15) 35.6  (12.30) 35.1  (10.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 61 participants 62 participants 243 participants
Female
3
   5.0%
2
   3.3%
4
   6.6%
1
   1.6%
10
   4.1%
Male
57
  95.0%
58
  96.7%
57
  93.4%
61
  98.4%
233
  95.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 61 participants 62 participants 243 participants
African American (Af Am)/African Heritage (Her)
21
  35.0%
17
  28.3%
18
  29.5%
20
  32.3%
76
  31.3%
American Indian or Alaskan Native (Nat)
0
   0.0%
0
   0.0%
2
   3.3%
2
   3.2%
4
   1.6%
Asian-Central/South Asian Her
1
   1.7%
1
   1.7%
1
   1.6%
0
   0.0%
3
   1.2%
Asian-Japanese/East Asian/South East Asian Her
0
   0.0%
1
   1.7%
2
   3.3%
0
   0.0%
3
   1.2%
White
37
  61.7%
39
  65.0%
36
  59.0%
39
  62.9%
151
  62.1%
Af Am/Af Her and Asian and White
0
   0.0%
0
   0.0%
1
   1.6%
0
   0.0%
1
   0.4%
Af Am/Af Her & Nat Hawaiian/other Pacific islander
0
   0.0%
0
   0.0%
1
   1.6%
0
   0.0%
1
   0.4%
Af Am/Af Her & White
0
   0.0%
2
   3.3%
0
   0.0%
0
   0.0%
2
   0.8%
American Indian or Alaskan Native & White
1
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.4%
Asian & White
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.6%
1
   0.4%
1.Primary Outcome
Title Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (mL) at Week 48 Using the Missing, Switch, Discontinuation Equals Failure (MSDF) Algorithm
Hide Description Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 was determined using the MSDF algorithm based on the current US Food and Drug Administration (FDA) definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-E Population comprised of all randomized participants who received at least one dose of investigational product.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title GSK1265744 10 mg GSK1265744 30 mg GSK1265744 60 mg Efavirenz 600 mg
Hide Arm/Group Description:
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Overall Number of Participants Analyzed 60 60 61 62
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
80
(70 to 90)
80
(70 to 90)
87
(78 to 95)
71
(60 to 82)
2.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm
Hide Description Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with HIV-1 RNA <400 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population.
Time Frame Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title GSK1265744 10 mg GSK1265744 30 mg GSK1265744 60 mg Efavirenz 600 mg
Hide Arm/Group Description:
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Overall Number of Participants Analyzed 60 60 61 62
Measure Type: Number
Unit of Measure: Percentage of participants
Baseline 0 0 0 0
Week 2 87 80 84 68
Week 4 93 93 93 68
Week 8 93 92 92 79
Week 12 90 85 89 73
Week 16 93 87 93 81
Week 24 93 87 92 79
Week 26 80 80 87 71
Week 28 85 83 85 73
Week 32 87 85 89 73
Week 36 87 85 90 73
Week 40 87 85 90 73
Week 48 83 85 89 73
Week 60 80 77 87 71
Week 72 77 75 85 68
Week 84 77 77 85 68
Week 96 75 77 85 65
3.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis
Hide Description Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <400 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on randomized therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period.
Time Frame Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles)
Arm/Group Title GSK1265744 10 mg GSK1265744 30 mg GSK1265744 60 mg Efavirenz 600 mg
Hide Arm/Group Description:
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Overall Number of Participants Analyzed 60 60 61 62
Measure Type: Number
Unit of Measure: Percentage of participants
Baseline; n=60, 60, 61, 62 Number Analyzed 60 participants 60 participants 61 participants 62 participants
0 0 0 0
Week 2; n=57, 56, 59, 59 Number Analyzed 57 participants 56 participants 59 participants 59 participants
91 86 86 71
Week 4; n=58, 57, 59, 57 Number Analyzed 58 participants 57 participants 59 participants 57 participants
97 98 97 74
Week 8; n=59, 56, 57, 55 Number Analyzed 59 participants 56 participants 57 participants 55 participants
95 98 98 91
Week 12; n=58, 52, 57, 51 Number Analyzed 58 participants 52 participants 57 participants 51 participants
97 100 98 92
Week 16; n=57, 54, 57, 52 Number Analyzed 57 participants 54 participants 57 participants 52 participants
98 100 100 96
Week 20; n=56, 54, 56, 47 Number Analyzed 56 participants 54 participants 56 participants 47 participants
100 100 100 100
Week 24; n=56, 53, 56, 48 Number Analyzed 56 participants 53 participants 56 participants 48 participants
100 100 100 100
Week 26; n=48, 50, 53, 44 Number Analyzed 48 participants 50 participants 53 participants 44 participants
100 100 100 100
Week 28; n=51, 52, 52, 45 Number Analyzed 51 participants 52 participants 52 participants 45 participants
100 100 100 100
Week 32; n=52, 53, 55, 45 Number Analyzed 52 participants 53 participants 55 participants 45 participants
100 100 98 100
Week 36; n=52, 53, 55, 45 Number Analyzed 52 participants 53 participants 55 participants 45 participants
100 100 100 100
Week 40; n=52, 53, 55, 45 Number Analyzed 52 participants 53 participants 55 participants 45 participants
100 100 100 100
Week 48; n=51, 53, 54, 44 Number Analyzed 51 participants 53 participants 54 participants 44 participants
98 98 100 100
Week 60; n=48, 48, 53, 44 Number Analyzed 48 participants 48 participants 53 participants 44 participants
96 100 100 98
Week 72; n=47, 48, 52, 42 Number Analyzed 47 participants 48 participants 52 participants 42 participants
98 96 100 100
Week 84; n=46, 48, 52, 42 Number Analyzed 46 participants 48 participants 52 participants 42 participants
100 98 100 100
Week 96; n=45, 48, 52, 40 Number Analyzed 45 participants 48 participants 52 participants 40 participants
96 100 100 100
4.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm
Hide Description Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population.
Time Frame Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Arm/Group Title GSK1265744 10 mg GSK1265744 30 mg GSK1265744 60 mg Efavirenz 600 mg
Hide Arm/Group Description:
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Overall Number of Participants Analyzed 60 60 61 62
Measure Type: Number
Unit of Measure: Percentage of participants
Baseline 0 0 0 0
Week 2 48 50 51 13
Week 4 80 78 70 24
Week 8 90 83 87 48
Week 12 88 75 82 61
Week 16 90 83 87 74
Week 24 87 85 87 74
Week 26 78 75 85 66
Week 28 85 78 85 69
Week 32 83 80 87 69
Week 36 85 82 85 71
Week 40 83 82 85 68
Week 48 80 80 87 71
Week 60 78 73 85 68
Week 72 72 73 85 68
Week 84 72 75 85 68
Week 96 68 75 84 63
Week 108 68 72 80 0
Week 120 65 73 80 0
Week 132 62 70 80 0
Week 144 58 67 77 0
Week 156 58 63 80 0
Week 168 57 65 75 0
Week 180 58 67 75 0
Week 192 57 65 74 0
Week 204 55 62 75 0
Week 216 55 63 77 0
Week 228 53 63 75 0
Week 240 50 62 74 0
Week 252 52 62 75 0
Week 264 53 62 75 0
Week 276 52 62 70 0
Week 288 50 62 74 0
Week 300 52 60 70 0
Week 312 52 52 70 0
5.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis
Hide Description Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period or open-label phase.
Time Frame Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles)
Arm/Group Title GSK1265744 10 mg GSK1265744 30 mg GSK1265744 60 mg Efavirenz 600 mg
Hide Arm/Group Description:
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Overall Number of Participants Analyzed 60 60 61 62
Measure Type: Number
Unit of Measure: Percentage of participants
Baseline; n=60, 60, 61, 62 Number Analyzed 60 participants 60 participants 61 participants 62 participants
0 0 0 0
Week 2; n=57, 56, 59, 59 Number Analyzed 57 participants 56 participants 59 participants 59 participants
51 54 53 14
Week 4; n=58, 57, 59, 57 Number Analyzed 58 participants 57 participants 59 participants 57 participants
83 82 73 26
Week 8; n=59, 56, 57, 55 Number Analyzed 59 participants 56 participants 57 participants 55 participants
92 89 93 55
Week 12; n=58, 52, 57, 51 Number Analyzed 58 participants 52 participants 57 participants 51 participants
95 88 91 76
Week 16; n=57, 54, 57, 52 Number Analyzed 57 participants 54 participants 57 participants 52 participants
95 94 93 87
Week 20; n=56, 54, 56, 47 Number Analyzed 56 participants 54 participants 56 participants 47 participants
91 98 98 91
Week 24; n=56, 53, 56, 48 Number Analyzed 56 participants 53 participants 56 participants 48 participants
93 98 95 96
Week 26; n=48, 50, 53, 44 Number Analyzed 48 participants 50 participants 53 participants 44 participants
98 94 98 93
Week 28; n=51, 52, 52, 45 Number Analyzed 51 participants 52 participants 52 participants 45 participants
100 94 100 96
Week 32; n=52, 53, 55, 45 Number Analyzed 52 participants 53 participants 55 participants 45 participants
96 94 96 96
Week 36; n=52, 53, 55, 45 Number Analyzed 52 participants 53 participants 55 participants 45 participants
98 96 95 98
Week 40; n=52, 53, 55, 45 Number Analyzed 52 participants 53 participants 55 participants 45 participants
96 96 95 93
Week 48; n=51, 53, 54, 44 Number Analyzed 51 participants 53 participants 54 participants 44 participants
92 92 98 98
Week 60; n=48, 48, 53, 44 Number Analyzed 48 participants 48 participants 53 participants 44 participants
94 96 98 95
Week 72; n=47, 48, 52, 42 Number Analyzed 47 participants 48 participants 52 participants 42 participants
91 92 100 100
Week 84; n=46, 48, 52, 42 Number Analyzed 46 participants 48 participants 52 participants 42 participants
91 94 100 100
Week 96; n=45, 48, 52, 40 Number Analyzed 45 participants 48 participants 52 participants 40 participants
89 98 98 98
Week 108; n=43, 46, 49, 0 Number Analyzed 43 participants 46 participants 49 participants 0 participants
95 96 100
Week 120; n=41, 46, 49, 0 Number Analyzed 41 participants 46 participants 49 participants 0 participants
95 100 98
Week 132; n=40, 46, 49, 0 Number Analyzed 40 participants 46 participants 49 participants 0 participants
95 96 100
Week 144; n=37, 45, 47, 0 Number Analyzed 37 participants 45 participants 47 participants 0 participants
92 93 98
Week 156; n=37, 42, 49, 0 Number Analyzed 37 participants 42 participants 49 participants 0 participants
95 95 98
Week 168; n=35, 43, 47, 0 Number Analyzed 35 participants 43 participants 47 participants 0 participants
94 95 98
Week 180; n=36, 41, 47, 0 Number Analyzed 36 participants 41 participants 47 participants 0 participants
97 100 98
Week 192; n=36, 40, 47, 0 Number Analyzed 36 participants 40 participants 47 participants 0 participants
94 100 96
Week 204; n=34, 39, 47, 0 Number Analyzed 34 participants 39 participants 47 participants 0 participants
97 97 98
Week 216; n=33, 39, 47, 0 Number Analyzed 33 participants 39 participants 47 participants 0 participants
100 100 98
Week 228; n=32, 39, 47, 0 Number Analyzed 32 participants 39 participants 47 participants 0 participants
100 100 98
Week 240; n=31, 39, 45, 0 Number Analyzed 31 participants 39 participants 45 participants 0 participants
97 97 100
Week 252; n=31, 38, 47, 0 Number Analyzed 31 participants 38 participants 47 participants 0 participants
100 97 98
Week 264; n=32, 38, 47, 0 Number Analyzed 32 participants 38 participants 47 participants 0 participants
100 100 98
Week 276; n=31, 38, 45, 0 Number Analyzed 31 participants 38 participants 45 participants 0 participants
100 100 96
Week 288; n=30, 38, 45, 0 Number Analyzed 30 participants 38 participants 45 participants 0 participants
100 100 100
Week 300; n=31, 37, 44, 0 Number Analyzed 31 participants 37 participants 44 participants 0 participants
97 100 95
Week 312; n=31, 33, 43, 0 Number Analyzed 31 participants 33 participants 43 participants 0 participants
100 97 100
Week 324; n=3, 4, 3, 0 Number Analyzed 3 participants 4 participants 3 participants 0 participants
100 100 100
6.Secondary Outcome
Title Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit
Hide Description Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed.
Time Frame Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title GSK1265744 10 mg GSK1265744 30 mg GSK1265744 60 mg Efavirenz 600 mg
Hide Arm/Group Description:
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Overall Number of Participants Analyzed 60 60 61 62
Mean (Standard Deviation)
Unit of Measure: Log10 copies per milliliter
Baseline; n=60, 60, 61, 62 Number Analyzed 60 participants 60 participants 61 participants 62 participants
4.424  (0.5834) 4.270  (0.6359) 4.428  (0.6418) 4.290  (0.6683)
Week 2; n=57, 56, 59, 59 Number Analyzed 57 participants 56 participants 59 participants 59 participants
1.883  (0.4551) 1.984  (0.5786) 1.939  (0.5071) 2.415  (0.5717)
Week 4; n=58, 57, 59, 57 Number Analyzed 58 participants 57 participants 59 participants 57 participants
1.706  (0.3245) 1.731  (0.4141) 1.725  (0.2750) 2.201  (0.5780)
Week 8; n=59, 56, 57, 55 Number Analyzed 59 participants 56 participants 57 participants 55 participants
1.695  (0.4114) 1.666  (0.3676) 1.666  (0.3926) 1.950  (0.5636)
Week 12; n=58, 52, 57, 51 Number Analyzed 58 participants 52 participants 57 participants 51 participants
1.643  (0.2506) 1.618  (0.0786) 1.641  (0.2033) 1.758  (0.4082)
Week 16; n=57, 54, 57, 52 Number Analyzed 57 participants 54 participants 57 participants 52 participants
1.619  (0.1418) 1.602  (0.0354) 1.616  (0.0956) 1.697  (0.3277)
Week 20; n=56, 54, 56, 47 Number Analyzed 56 participants 54 participants 56 participants 47 participants
1.623  (0.1175) 1.596  (0.0346) 1.599  (0.0591) 1.649  (0.1962)
Week 24; n=56, 53, 56, 48 Number Analyzed 56 participants 53 participants 56 participants 48 participants
1.615  (0.1010) 1.597  (0.0360) 1.603  (0.0532) 1.610  (0.0902)
Week 26; n=48, 50, 53, 44 Number Analyzed 48 participants 50 participants 53 participants 44 participants
1.595  (0.0270) 1.602  (0.0434) 1.594  (0.0194) 1.610  (0.0742)
Week 28; n=51, 52, 52, 45 Number Analyzed 51 participants 52 participants 52 participants 45 participants
1.591  (0.0000) 1.607  (0.0565) 1.591  (0.0000) 1.600  (0.0451)
Week 32; n=52, 53, 55, 45 Number Analyzed 52 participants 53 participants 55 participants 45 participants
1.609  (0.0955) 1.620  (0.1277) 1.618  (0.1742) 1.614  (0.1022)
Week 36; n=52, 53, 55, 45 Number Analyzed 52 participants 53 participants 55 participants 45 participants
1.604  (0.0782) 1.610  (0.1070) 1.606  (0.0722) 1.607  (0.1068)
Week 40; n=52, 53, 55, 45 Number Analyzed 52 participants 53 participants 55 participants 45 participants
1.612  (0.1206) 1.618  (0.1214) 1.608  (0.0752) 1.607  (0.0650)
Week 48; n=51, 53, 54, 44 Number Analyzed 51 participants 53 participants 54 participants 44 participants
1.686  (0.4077) 1.654  (0.3673) 1.598  (0.0508) 1.596  (0.0247)
Week 60; n=48, 48, 53, 44 Number Analyzed 48 participants 48 participants 53 participants 44 participants
1.648  (0.2643) 1.598  (0.0300) 1.594  (0.0205) 1.657  (0.3948)
Week 72; n=47, 48, 52, 42 Number Analyzed 47 participants 48 participants 52 participants 42 participants
1.625  (0.1584) 1.697  (0.4705) 1.591  (0.0000) 1.592  (0.0065)
Week 84; n=46, 48, 52, 42 Number Analyzed 46 participants 48 participants 52 participants 42 participants
1.645  (0.1838) 1.643  (0.2896) 1.592  (0.0059) 1.591  (0.0017)
Week 96; n=45, 48, 52, 40 Number Analyzed 45 participants 48 participants 52 participants 40 participants
1.681  (0.2783) 1.603  (0.0861) 1.596  (0.0227) 1.598  (0.0467)
Week 108; n=43, 46, 49, 0 Number Analyzed 43 participants 46 participants 49 participants 0 participants
1.634  (0.1979) 1.609  (0.0885) 1.591  (0.0000)
Week 120; n=41, 46, 49, 0 Number Analyzed 41 participants 46 participants 49 participants 0 participants
1.638  (0.2216) 1.591  (0.0000) 1.618  (0.1884)
Week 132; n=40, 46, 49, 0 Number Analyzed 40 participants 46 participants 49 participants 0 participants
1.646  (0.2491) 1.631  (0.2097) 1.591  (0.0000)
Week 144; n=37, 45, 47, 0 Number Analyzed 37 participants 45 participants 47 participants 0 participants
1.682  (0.4027) 1.698  (0.5940) 1.630  (0.2656)
Week 156; n=37, 42, 49, 0 Number Analyzed 37 participants 42 participants 49 participants 0 participants
1.634  (0.1850) 1.603  (0.0520) 1.619  (0.1833)
Week 168; n=35, 43, 47, 0 Number Analyzed 35 participants 43 participants 47 participants 0 participants
1.665  (0.3351) 1.642  (0.2908) 1.603  (0.0810)
Week 180; n=36, 41, 47, 0 Number Analyzed 36 participants 41 participants 47 participants 0 participants
1.613  (0.1324) 1.591  (0.0000) 1.600  (0.0584)
Week 192; n=36, 40, 47, 0 Number Analyzed 36 participants 40 participants 47 participants 0 participants
1.689  (0.4119) 1.591  (0.0000) 1.699  (0.6971)
Week 204; n=34, 39, 47, 0 Number Analyzed 34 participants 39 participants 47 participants 0 participants
1.628  (0.2162) 1.595  (0.0252) 1.634  (0.2936)
Week 216; n=33, 39, 47, 0 Number Analyzed 33 participants 39 participants 47 participants 0 participants
1.591  (0.0000) 1.592  (0.0052) 1.634  (0.2948)
Week 228; n=32, 39, 47, 0 Number Analyzed 32 participants 39 participants 47 participants 0 participants
1.591  (0.0000) 1.591  (0.0000) 1.625  (0.2351)
Week 240; n=31, 39, 45, 0 Number Analyzed 31 participants 39 participants 45 participants 0 participants
1.596  (0.0268) 1.601  (0.0465) 1.591  (0.0000)
Week 252; n=31, 38, 47, 0 Number Analyzed 31 participants 38 participants 47 participants 0 participants
1.591  (0.0000) 1.599  (0.0461) 1.593  (0.0157)
Week 264; n=32, 38, 47, 0 Number Analyzed 32 participants 38 participants 47 participants 0 participants
1.591  (0.0000) 1.591  (0.0000) 1.617  (0.1788)
Week 276; n=31, 38, 45, 0 Number Analyzed 31 participants 38 participants 45 participants 0 participants
1.591  (0.0000) 1.591  (0.0000) 1.618  (0.1398)
Week 288; n=30, 38, 45, 0 Number Analyzed 30 participants 38 participants 45 participants 0 participants
1.591  (0.000) 1.592  (0.0052) 1.591  (0.0000)
Week 300; n=31, 37, 44, 0 Number Analyzed 31 participants 37 participants 44 participants 0 participants
1.601  (0.0551) 1.591  (0.0000) 1.625  (0.1753)
Week 312; n=31, 33, 43, 0 Number Analyzed 31 participants 33 participants 43 participants 0 participants
1.597  (0.0214) 1.600  (0.0494) 1.591  (0.0000)
Week 324; n=3, 4, 3, 0 Number Analyzed 3 participants 4 participants 3 participants 0 participants
1.591  (0.0000) 1.591  (0.0000) 1.591  (0.0000)
7.Secondary Outcome
Title Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit
Hide Description Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
Time Frame Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title GSK1265744 10 mg GSK1265744 30 mg GSK1265744 60 mg Efavirenz 600 mg
Hide Arm/Group Description:
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Overall Number of Participants Analyzed 60 60 61 62
Mean (Standard Deviation)
Unit of Measure: Log10 copies per milliliter
Week 2; n=57, 56, 59, 59 Number Analyzed 57 participants 56 participants 59 participants 59 participants
-2.534  (0.4175) -2.306  (0.5937) -2.504  (0.4311) -1.875  (0.4273)
Week 4; n=58, 57, 59, 57 Number Analyzed 58 participants 57 participants 59 participants 57 participants
-2.731  (0.4158) -2.550  (0.6300) -2.718  (0.4981) -2.092  (0.4866)
Week 8; n=59, 56, 57, 55 Number Analyzed 59 participants 56 participants 57 participants 55 participants
-2.733  (0.6374) -2.611  (0.6938) -2.741  (0.7034) -2.344  (0.6765)
Week 12; n=58, 52, 57, 51 Number Analyzed 58 participants 52 participants 57 participants 51 participants
-2.793  (0.5574) -2.634  (0.6308) -2.790  (0.6515) -2.533  (0.6580)
Week 16; n=57, 54, 57, 52 Number Analyzed 57 participants 54 participants 57 participants 52 participants
-2.823  (0.5118) -2.659  (0.6363) -2.815  (0.6170) -2.602  (0.6698)
Week 20; n=56, 54, 56, 47 Number Analyzed 56 participants 54 participants 56 participants 47 participants
-2.823  (0.5329) -2.665  (0.6418) -2.834  (0.6250) -2.666  (0.6512)
Week 24; n=56, 53, 56, 48 Number Analyzed 56 participants 53 participants 56 participants 48 participants
-2.831  (0.5465) -2.659  (0.6488) -2.830  (0.6304) -2.694  (0.6843)
Week 26; n=48, 50, 53, 44 Number Analyzed 48 participants 50 participants 53 participants 44 participants
-2.788  (0.5023) -2.662  (0.6670) -2.792  (0.6014) -2.733  (0.6879)
Week 28; n=51, 52, 52, 45 Number Analyzed 51 participants 52 participants 52 participants 45 participants
-2.784  (0.4944) -2.663  (0.6356) -2.791  (0.5831) -2.714  (0.6873)
Week 32; n=52, 53, 55, 45 Number Analyzed 52 participants 53 participants 55 participants 45 participants
-2.763  (0.5164) -2.636  (0.6598) -2.781  (0.6146) -2.672  (0.6812)
Week 36; n=52, 53, 55, 45 Number Analyzed 52 participants 53 participants 55 participants 45 participants
-2.768  (0.5000) -2.646  (0.6786) -2.792  (0.5803) -2.679  (0.6776)
Week 40; n=52, 53, 55, 45 Number Analyzed 52 participants 53 participants 55 participants 45 participants
-2.760  (0.5143) -2.638  (0.6581) -2.790  (0.5736) -2.679  (0.6817)
Week 48; n=51, 53, 54, 44 Number Analyzed 51 participants 53 participants 54 participants 44 participants
-2.682  (0.6637) -2.602  (0.7855) -2.799  (0.5946) -2.676  (0.6773)
Week 60; n=48, 48, 53, 44 Number Analyzed 48 participants 48 participants 53 participants 44 participants
-2.729  (0.6405) -2.613  (0.6068) -2.787  (0.5920) -2.615  (0.8875)
Week 72; n=47, 48, 52, 42 Number Analyzed 47 participants 48 participants 52 participants 42 participants
-2.745  (0.5229) -2.514  (0.7487) -2.783  (0.6009) -2.738  (0.6415)
Week 84; n=46, 48, 52, 42 Number Analyzed 46 participants 48 participants 52 participants 42 participants
-2.722  (0.5650) -2.568  (0.7144) -2.782  (0.5994) -2.739  (0.6431)
Week 96; n=45, 48, 52, 40 Number Analyzed 45 participants 48 participants 52 participants 40 participants
-2.670  (0.5277) -2.608  (0.6342) -2.778  (0.5943) -2.731  (0.6586)
Week 108; n=43, 46, 49, 0 Number Analyzed 43 participants 46 participants 49 participants 0 participants
-2.723  (0.5396) -2.632  (0.6265) -2.743  (0.5851)
Week 120; n=41, 46, 49, 0 Number Analyzed 41 participants 46 participants 49 participants 0 participants
-2.712  (0.5477) -2.650  (0.6137) -2.717  (0.6180)
Week 132; n=40, 46, 49, 0 Number Analyzed 40 participants 46 participants 49 participants 0 participants
-2.705  (0.5504) -2.610  (0.6718) -2.743  (0.5851)
Week 144; n=37, 45, 47, 0 Number Analyzed 37 participants 45 participants 47 participants 0 participants
-2.690  (0.6615) -2.555  (0.9008) -2.703  (0.6903)
Week 156; n=37, 42, 49, 0 Number Analyzed 37 participants 42 participants 49 participants 0 participants
-2.737  (0.5476) -2.645  (0.6129) -2.716  (0.6309)
Week 168; n=35, 43, 47, 0 Number Analyzed 35 participants 43 participants 47 participants 0 participants
-2.680  (0.6170) -2.592  (0.7138) -2.700  (0.5907)
Week 180; n=36, 41, 47, 0 Number Analyzed 36 participants 41 participants 47 participants 0 participants
-2.747  (0.4984) -2.628  (0.6251) -2.767  (0.5672)
Week 192; n=36, 40, 47, 0 Number Analyzed 36 participants 40 participants 47 participants 0 participants
-2.671  (0.6656) -2.641  (0.6272) -2.667  (0.8708)
Week 204; n=34, 39, 47, 0 Number Analyzed 34 participants 39 participants 47 participants 0 participants
-2.750  (0.5359) -2.632  (0.6353) -2.718  (0.7294)
Week 216; n=33, 39, 47, 0 Number Analyzed 33 participants 39 participants 47 participants 0 participants
-2.787  (0.4956) -2.636  (0.6337) -2.718  (0.6660)
Week 228; n=32, 39, 47, 0 Number Analyzed 32 participants 39 participants 47 participants 0 participants
-2.770  (0.4940) -2.636  (0.6346) -2.726  (0.6757)
Week 240; n=31, 39, 45, 0 Number Analyzed 31 participants 39 participants 45 participants 0 participants
-2.798  (0.4923) -2.627  (0.6181) -2.736  (0.5861)
Week 252; n=31, 38, 47, 0 Number Analyzed 31 participants 38 participants 47 participants 0 participants
-2.787  (0.5092) -2.601  (0.6209) -2.758  (0.5875)
Week 264; n=32, 38, 47, 0 Number Analyzed 32 participants 38 participants 47 participants 0 participants
-2.780  (0.5022) -2.659  (0.6264) -2.734  (0.6213)
Week 276; n=31, 38, 45, 0 Number Analyzed 31 participants 38 participants 45 participants 0 participants
-2.786  (0.5095) -2.659  (0.6264) -2.764  (0.6002)
Week 288; n=30, 38, 45, 0 Number Analyzed 30 participants 38 participants 45 participants 0 participants
-2.768  (0.5083) -2.659  (0.6246) -2.775  (0.5984)
Week 300; n=31, 37, 44, 0 Number Analyzed 31 participants 37 participants 44 participants 0 participants
-2.776  (0.5062) -2.664  (0.6344) -2.730  (0.6786)
Week 312; n=31, 33, 43, 0 Number Analyzed 31 participants 33 participants 43 participants 0 participants
-2.780  (0.5085) -2.569  (0.6037) -2.789  (0.5825)
Week 324; n=3, 4, 3, 0 Number Analyzed 3 participants 4 participants 3 participants 0 participants
-2.488  (0.1409) -2.215  (0.4624) -2.438  (0.5904)
8.Secondary Outcome
Title Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease
Hide Description HIV-1 associated conditions were assessed according to the 1993 Centers for Disease Control and Prevention (CDC) Revised Classification System for HIV Infection in Adults. The clinical categories of HIV infection as per CDC system are class A=Asymptomatic HIV infection or lymphadenopathy or acute HIV infection; class B=symptomatic non-acquired immunodeficiency syndrome (AIDS) conditions and class C=AIDS indicator conditions. Number of participants experiencing disease progression is presented, where disease progression is defined as the progression from Baseline HIV disease status as follows: CDC class A at Baseline to CDC class C event; CDC Class B at Baseline to CDC Class C event; CDC Class C at Baseline to new CDC Class C event; and CDC class A, B or C at Baseline to death.
Time Frame Up to Week 324
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title GSK1265744 10 mg GSK1265744 30 mg GSK1265744 60 mg Efavirenz 600 mg
Hide Arm/Group Description:
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Overall Number of Participants Analyzed 60 60 61 62
Measure Type: Count of Participants
Unit of Measure: Participants
CDC Class A to CDC Class C
1
   1.7%
1
   1.7%
0
   0.0%
0
   0.0%
CDC Class B to CDC Class C
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
CDC Class C to new CDC Class C
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
CDC Class A, B or C to Death
0
   0.0%
1
   1.7%
1
   1.6%
0
   0.0%
9.Secondary Outcome
Title Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96
Hide Description CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed.
Time Frame Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
Arm/Group Title GSK1265744 10 mg GSK1265744 30 mg GSK1265744 60 mg Efavirenz 600 mg
Hide Arm/Group Description:
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Overall Number of Participants Analyzed 60 60 61 62
Mean (Standard Deviation)
Unit of Measure: Cells per cubic millimeter
Baseline; n=60, 60, 61, 62 Number Analyzed 60 participants 60 participants 61 participants 62 participants
445.5  (155.60) 444.9  (190.98) 459.0  (170.64) 456.5  (196.11)
Week 2; n=57, 56, 59, 59 Number Analyzed 57 participants 56 participants 59 participants 59 participants
544.0  (197.54) 525.1  (181.29) 549.3  (206.68) 487.0  (222.84)
Week 4; n=58, 57, 59, 57 Number Analyzed 58 participants 57 participants 59 participants 57 participants
580.5  (230.40) 522.0  (205.80) 545.8  (196.79) 509.9  (198.21)
Week 8; n=58, 56, 57, 55 Number Analyzed 58 participants 56 participants 57 participants 55 participants
576.6  (196.55) 555.2  (210.92) 544.3  (176.01) 531.4  (175.95)
Week 12; n=58, 53, 57, 51 Number Analyzed 58 participants 53 participants 57 participants 51 participants
588.4  (208.15) 599.0  (226.06) 596.6  (181.00) 564.3  (222.99)
Week 16; n=57, 54, 57, 52 Number Analyzed 57 participants 54 participants 57 participants 52 participants
608.3  (200.34) 595.8  (197.47) 599.7  (166.77) 594.4  (212.63)
Week 20; n=56, 54, 56, 49 Number Analyzed 56 participants 54 participants 56 participants 49 participants
607.3  (204.87) 607.4  (199.27) 636.6  (225.04) 607.7  (186.36)
Week 24; n=56, 53, 56, 47 Number Analyzed 56 participants 53 participants 56 participants 47 participants
614.6  (194.13) 626.5  (210.63) 658.0  (253.19) 599.5  (219.52)
Week 26; n=48, 50, 53, 45 Number Analyzed 48 participants 50 participants 53 participants 45 participants
632.8  (210.93) 629.5  (207.34) 645.8  (188.61) 625.7  (196.46)
Week 28; n=49, 52, 52, 45 Number Analyzed 49 participants 52 participants 52 participants 45 participants
652.2  (225.32) 635.9  (217.52) 653.3  (261.11) 635.7  (224.72)
Week 32; n=52, 53, 55, 45 Number Analyzed 52 participants 53 participants 55 participants 45 participants
638.1  (192.54) 650.8  (209.66) 665.2  (246.84) 663.8  (257.25)
Week 36; n=52, 53, 55, 45 Number Analyzed 52 participants 53 participants 55 participants 45 participants
638.7  (198.05) 658.6  (226.51) 720.3  (257.85) 651.5  (212.15)
Week 40; n=52, 53, 55, 45 Number Analyzed 52 participants 53 participants 55 participants 45 participants
650.2  (218.40) 658.5  (204.08) 667.6  (187.30) 687.9  (241.35)
Week 48; n=51, 53, 54, 44 Number Analyzed 51 participants 53 participants 54 participants 44 participants
677.3  (219.75) 687.2  (227.06) 713.8  (215.70) 732.6  (273.19)
Week 60; n=48, 47, 53, 44 Number Analyzed 48 participants 47 participants 53 participants 44 participants
668.1  (222.61) 720.9  (268.74) 719.8  (219.04) 733.9  (238.90)
Week 72; n=47, 48, 52, 42 Number Analyzed 47 participants 48 participants 52 participants 42 participants
683.2  (242.75) 651.3  (217.19) 710.9  (259.89) 722.5  (263.47)
Week 84; n=46, 48, 52, 42 Number Analyzed 46 participants 48 participants 52 participants 42 participants
718.3  (212.59) 736.9  (271.85) 735.0  (236.25) 744.7  (250.90)
Week 96; n=46, 46, 52, 41 Number Analyzed 46 participants 46 participants 52 participants 41 participants
726.2  (272.28) 722.9  (246.22) 743.1  (242.23) 747.8  (263.27)
10.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count Over Time by Visit
Hide Description CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
Time Frame Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population.Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
Arm/Group Title GSK1265744 10 mg GSK1265744 30 mg GSK1265744 60 mg Efavirenz 600 mg
Hide Arm/Group Description:
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Overall Number of Participants Analyzed 60 60 61 62
Mean (Standard Deviation)
Unit of Measure: Cells per cubic millimeter
Week 2; n=57, 56, 59, 59 Number Analyzed 57 participants 56 participants 59 participants 59 participants
92.6  (112.44) 79.5  (118.15) 91.7  (127.92) 24.8  (138.47)
Week 4; n=58, 57, 59, 57 Number Analyzed 58 participants 57 participants 59 participants 57 participants
136.4  (157.36) 76.9  (107.01) 88.2  (110.01) 46.0  (106.35)
Week 8; n=58, 56, 57, 55 Number Analyzed 58 participants 56 participants 57 participants 55 participants
129.9  (123.47) 117.8  (132.19) 90.5  (148.25) 65.6  (120.25)
Week 12; n=58, 53, 57, 51 Number Analyzed 58 participants 53 participants 57 participants 51 participants
140.5  (142.86) 140.8  (165.02) 145.2  (142.24) 103.4  (125.39)
Week 16; n=57, 54, 57, 52 Number Analyzed 57 participants 54 participants 57 participants 52 participants
159.3  (115.36) 142.2  (145.64) 148.3  (131.81) 135.5  (153.48)
Week 20; n=56, 54, 56, 49 Number Analyzed 56 participants 54 participants 56 participants 49 participants
165.2  (146.90) 153.8  (150.40) 182.6  (142.18) 149.0  (117.44)
Week 24; n=56, 53, 56, 47 Number Analyzed 56 participants 53 participants 56 participants 47 participants
172.5  (112.04) 180.9  (161.43) 204.0  (166.78) 143.4  (145.18)
Week 26; n=48, 50, 53, 45 Number Analyzed 48 participants 50 participants 53 participants 45 participants
186.4  (153.99) 177.7  (146.84) 194.7  (149.66) 166.4  (145.11)
Week 28; n=49, 52, 52, 45 Number Analyzed 49 participants 52 participants 52 participants 45 participants
205.0  (164.91) 188.1  (132.08) 193.3  (154.43) 178.2  (150.25)
Week 32; n=52, 53, 55, 45 Number Analyzed 52 participants 53 participants 55 participants 45 participants
191.4  (151.79) 205.2  (145.53) 209.9  (157.56) 197.4  (170.48)
Week 36; n=52, 53, 55, 45 Number Analyzed 52 participants 53 participants 55 participants 45 participants
192.0  (165.97) 213.0  (144.89) 265.0  (169.42) 185.2  (152.91)
Week 40; n=52, 53, 55, 45 Number Analyzed 52 participants 53 participants 55 participants 45 participants
203.6  (171.74) 212.8  (180.38) 212.3  (114.67) 221.5  (188.99)
Week 48; n=51, 53, 54, 44 Number Analyzed 51 participants 53 participants 54 participants 44 participants
235.1  (179.89) 241.6  (182.90) 259.0  (154.21) 262.5  (201.33)
Week 60; n=48, 47, 53, 44 Number Analyzed 48 participants 47 participants 53 participants 44 participants
217.7  (152.92) 269.4  (188.34) 266.1  (156.03) 263.8  (181.15)
Week 72; n=47, 48, 52, 42 Number Analyzed 47 participants 48 participants 52 participants 42 participants
232.0  (191.05) 201.4  (206.54) 254.0  (189.26) 257.1  (216.41)
Week 84; n=46, 48, 52, 42 Number Analyzed 46 participants 48 participants 52 participants 42 participants
261.5  (171.65) 287.0  (207.10) 278.1  (166.11) 279.4  (191.30)
Week 96; n=46, 46, 52, 41 Number Analyzed 46 participants 46 participants 52 participants 41 participants
269.4  (204.32) 267.5  (196.27) 286.2  (181.50) 281.7  (232.90)
Week 108; n=43, 46, 49, 0 Number Analyzed 43 participants 46 participants 49 participants 0 participants
296.2  (215.21) 304.3  (195.30) 288.4  (184.61)
Week 120; n=41, 46, 49, 0 Number Analyzed 41 participants 46 participants 49 participants 0 participants
266.1  (173.09) 279.3  (181.10) 307.2  (225.39)
Week 132; n=40, 46, 49, 0 Number Analyzed 40 participants 46 participants 49 participants 0 participants
297.1  (167.59) 305.2  (184.98) 313.2  (168.30)
Week 144; n=37, 45, 46, 0 Number Analyzed 37 participants 45 participants 46 participants 0 participants
330.7  (225.42) 308.9  (224.63) 322.4  (224.57)
Week 156; n=37, 42, 49, 0 Number Analyzed 37 participants 42 participants 49 participants 0 participants
334.5  (213.79) 319.2  (182.15) 320.4  (187.58)
Week 168; n=35, 43, 47, 0 Number Analyzed 35 participants 43 participants 47 participants 0 participants
338.1  (252.13) 332.4  (222.37) 361.3  (198.98)
Week 180; n=36, 41, 47, 0 Number Analyzed 36 participants 41 participants 47 participants 0 participants
338.0  (218.72) 348.6  (203.73) 384.2  (192.86)
Week 192; n=35, 40, 47, 0 Number Analyzed 35 participants 40 participants 47 participants 0 participants
300.8  (168.24) 351.0  (205.56) 342.3  (204.83)
Week 204; n=34, 39, 47, 0 Number Analyzed 34 participants 39 participants 47 participants 0 participants
369.5  (196.17) 332.9  (179.28) 340.0  (191.82)
Week 216; n=33, 39, 47, 0 Number Analyzed 33 participants 39 participants 47 participants 0 participants
397.0  (202.03) 373.4  (188.28) 357.8  (199.87)
Week 228; n=32, 39, 47, 0 Number Analyzed 32 participants 39 participants 47 participants 0 participants
331.8  (168.64) 366.5  (231.25) 383.7  (253.17)
Week 240; n=32, 39, 47, 0 Number Analyzed 32 participants 39 participants 47 participants 0 participants
356.5  (195.99) 395.9  (205.55) 408.4  (201.05)
Week 252; n=31, 38, 47, 0 Number Analyzed 31 participants 38 participants 47 participants 0 participants
400.3  (183.36) 343.7  (196.09) 383.1  (217.20)
Week 264; n=32, 38, 47, 0 Number Analyzed 32 participants 38 participants 47 participants 0 participants
344.4  (160.38) 365.0  (210.00) 391.8  (222.00)
Week 276; n=31, 38, 46, 0 Number Analyzed 31 participants 38 participants 46 participants 0 participants
398.3  (250.45) 350.3  (210.98) 362.2  (243.30)
Week 288; n=30, 38, 45, 0 Number Analyzed 30 participants 38 participants 45 participants 0 participants
411.0  (161.93) 383.5  (279.75) 337.1  (187.13)
Week 300; n=30, 37, 44, 0 Number Analyzed 30 participants 37 participants 44 participants 0 participants
437.7  (196.33) 404.4  (239.11) 353.5  (200.23)
Week 312; n=30, 34, 43, 0 Number Analyzed 30 participants 34 participants 43 participants 0 participants
335.0  (176.73) 433.0  (264.63) 407.0  (178.06)
Week 324; n=3, 4, 3, 0 Number Analyzed 3 participants 4 participants 3 participants 0 participants
402.0  (197.55) 276.0  (278.28) 272.0  (277.44)
11.Secondary Outcome
Title Number of Participants With Treatment Emergent Phenotypic Resistance
Hide Description Plasma samples were collected for drug resistance testing. Phenotypic resistance data for the following drugs under integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), NRTI and proteasome inhibitor drug classes is presented for participants with confirmed virologic failure: GSK1265744, Raltegravir [RAL], Delavirdine [DLV], Efavirenz [EFV], Etravirine [ETR], Nevirapine (NVP), RPV, 3TC, ABC, FTC, TDF, Zidovudine [ZDV], Stavudine [d4T], Didanosine [ddI], Atazanavir/ritonavir [ATV/r], Darunavir (DRV)/r, Fosamprenavir/r [FPV/r], Indinavir/r [IDV/r], Lopinavir/r [LPV/r], Nelfinavir [NFV], Ritonavir [RTV], Saquinavir/r [SQV/r], Tipranavir/r [TPV/r]. On-treatment Phenotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment phenotypic resistance data, excluding participants who are not protocol-defined virologic failures.
Time Frame Up to Week 324
Hide Outcome Measure Data
Hide Analysis Population Description
On-treatment Phenotypic Resistance Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title GSK1265744 10 mg GSK1265744 30 mg GSK1265744 60 mg Efavirenz 600 mg
Hide Arm/Group Description:
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Overall Number of Participants Analyzed 6 2 2 5
Measure Type: Count of Participants
Unit of Measure: Participants
INI, GSK1265744; Resistant; n=5, 1, 2, 2 Number Analyzed 5 participants 1 participants 2 participants 2 participants
2
  40.0%
0
   0.0%
1
  50.0%
0
   0.0%
INI, GSK1265744; Sensitive; n=5, 1, 2, 2 Number Analyzed 5 participants 1 participants 2 participants 2 participants
3
  60.0%
1
 100.0%
1
  50.0%
2
 100.0%
INI, RAL; Resistant; n=5, 1, 2, 2 Number Analyzed 5 participants 1 participants 2 participants 2 participants
3
  60.0%
0
   0.0%
1
  50.0%
0
   0.0%
INI, RAL; Sensitive; n=5, 1, 2, 2 Number Analyzed 5 participants 1 participants 2 participants 2 participants
2
  40.0%
1
 100.0%
1
  50.0%
2
 100.0%
NNRTI, DLV; Resistant; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
3
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
NNRTI, DLV; Sensitive; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
3
  50.0%
2
 100.0%
2
 100.0%
5
 100.0%
NNRTI, EFV; Resistant; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
3
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
NNRTI, EFV; Sensitive; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
3
  50.0%
2
 100.0%
2
 100.0%
5
 100.0%
NNRTI, ETR; Resistant; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
3
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
NNRTI, ETR; Partially sensitive; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
NNRTI, ETR; Sensitive; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
3
  50.0%
2
 100.0%
2
 100.0%
5
 100.0%
NNRTI, NVP; Resistant; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
3
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
NNRTI, NVP; Sensitive; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
3
  50.0%
2
 100.0%
2
 100.0%
5
 100.0%
NNRTI, RPV; Resistant; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
3
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
NNRTI, RPV; Sensitive; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
3
  50.0%
2
 100.0%
2
 100.0%
5
 100.0%
NRTI, 3TC; Resistant; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
NRTI, 3TC; Sensitive; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
6
 100.0%
2
 100.0%
2
 100.0%
5
 100.0%
NRTI, ABC; Resistant; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
NRTI, ABC; Partially sensitive; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
NRTI, ABC; Sensitive; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
6
 100.0%
2
 100.0%
2
 100.0%
5
 100.0%
NRTI, FTC; Resistant; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
NRTI, FTC; Sensitive; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
6
 100.0%
2
 100.0%
2
 100.0%
5
 100.0%
NRTI, TDF; Resistant; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
NRTI, TDF; Partially sensitive; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
NRTI, TDF; Sensitive; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
5
  83.3%
2
 100.0%
2
 100.0%
5
 100.0%
NRTI, ZDV; Resistant; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
2
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
NRTI, ZDV; Sensitive; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
4
  66.7%
2
 100.0%
2
 100.0%
5
 100.0%
NRTI, d4T; Resistant; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
NRTI, d4T; Sensitive; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
6
 100.0%
2
 100.0%
2
 100.0%
5
 100.0%
NRTI, ddI; Resistant; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
NRTI, ddI; Partially sensitive; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
NRTI, ddI; Sensitive; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
6
 100.0%
2
 100.0%
2
 100.0%
5
 100.0%
PI, ATV/r; Resistant; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
PI, ATV/r; Sensitive; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
6
 100.0%
2
 100.0%
2
 100.0%
5
 100.0%
PI, DRV/r; Resistant; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
PI, DRV/r; Partially sensitive; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
PI, DRV/r; Sensitive; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
6
 100.0%
2
 100.0%
2
 100.0%
5
 100.0%
PI, FPV/r; Resistant; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
PI, FPV/r; Partially sensitive; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
PI, FPV/r; Sensitive; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
6
 100.0%
2
 100.0%
2
 100.0%
5
 100.0%
PI, IDV/r; Resistant; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
PI, IDV/r; Sensitive; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
6
 100.0%
2
 100.0%
2
 100.0%
5
 100.0%
PI, LPV/r; Resistant; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
PI, LPV/r; Partially sensitive; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
PI, LPV/r; Sensitive; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
6
 100.0%
2
 100.0%
2
 100.0%
5
 100.0%
PI, NFV; Resistant; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
PI, NFV; Sensitive; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
6
 100.0%
2
 100.0%
2
 100.0%
5
 100.0%
PI, RTV; Resistant; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
PI, RTV; Sensitive; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
6
 100.0%
2
 100.0%
2
 100.0%
5
 100.0%
PI, SQV/r; Resistant; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
PI, SQV/r; Partially sensitive; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
PI, SQV/r; Sensitive; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
6
 100.0%
2
 100.0%
2
 100.0%
5
 100.0%
PI, TPV/r; Resistant; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
PI, TPV/r; Partially sensitive; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
PI, TPV/r; Sensitive; n=6, 2, 2, 5 Number Analyzed 6 participants 2 participants 2 participants 5 participants
6
 100.0%
2
 100.0%
2
 100.0%
5
 100.0%
12.Secondary Outcome
Title Number of Participants With Treatment Emergent Genotypic Mutations Associated With Development of Resistance
Hide Description Plasma samples were collected for drug resistance testing. The treatment emergent INI mutations associated with development of resistance to RAL, ELV, dolutegravir (DTG) or GSK1265744 and major resistance mutations to other classes (NRTI, NNRTI, PI) as defined by International AIDS society (IAS)-United States of America (USA) are presented. On-treatment Genotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment genotypic resistance data, excluding participants who are not protocol-defined virologic failures.
Time Frame Up to Week 324
Hide Outcome Measure Data
Hide Analysis Population Description
On-treatment Genotypic resistance Population
Arm/Group Title GSK1265744 10 mg GSK1265744 30 mg GSK1265744 60 mg Efavirenz 600 mg
Hide Arm/Group Description:
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Overall Number of Participants Analyzed 6 2 2 5
Measure Type: Count of Participants
Unit of Measure: Participants
Any INI mutation
3
  50.0%
0
   0.0%
1
  50.0%
0
   0.0%
Any mutation to other classes
4
  66.7%
0
   0.0%
1
  50.0%
0
   0.0%
13.Secondary Outcome
Title Number of Participants With Adherence to Study Treatment
Hide Description Number of participants with >=90% adherence to study treatment based on pill count is summarized.
Time Frame Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312
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Hide Analysis Population Description
ITT-E Population. Only participants who were dispensed and returned drug on scheduled visits were included in the analysis (represented by n=X in category titles)
Arm/Group Title GSK1265744 10 mg GSK1265744 30 mg GSK1265744 60 mg Efavirenz 600 mg
Hide Arm/Group Description:
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Overall Number of Participants Analyzed 57 55 56 52
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline; n=57, 55, 56, 52 Number Analyzed 57 participants 55 participants 56 participants 52 participants
53
  93.0%
51
  92.7%
55
  98.2%
48
  92.3%
Week 4; n=54, 52, 53, 50 Number Analyzed 54 participants 52 participants 53 participants 50 participants
46
  85.2%
49
  94.2%
52
  98.1%
44
  88.0%
Week 8; n=53, 50, 56, 48 Number Analyzed 53 participants 50 participants 56 participants 48 participants
49
  92.5%
45
  90.0%
53
  94.6%
47
  97.9%
Week 12; n=55, 48, 53, 48 Number Analyzed 55 participants 48 participants 53 participants 48 participants
44
  80.0%
40
  83.3%
46
  86.8%
43
  89.6%
Week 16; n=53, 51, 53, 44 Number Analyzed 53 participants 51 participants 53 participants 44 participants
44
  83.0%
45
  88.2%
50
  94.3%
42
  95.5%
Week 20; n=51, 49, 55, 44 Number Analyzed 51 participants 49 participants 55 participants 44 participants
45
  88.2%
40
  81.6%
51
  92.7%
41
  93.2%
Week 24; n=51, 46, 51, 43 Number Analyzed 51 participants 46 participants 51 participants 43 participants
47
  92.2%
41
  89.1%
48
  94.1%
39
  90.7%
Week 28; n=49, 48, 53, 41 Number Analyzed 49 participants 48 participants 53 participants 41 participants
45
  91.8%
46
  95.8%
48
  90.6%
35
  85.4%
Week 32; n=47, 48, 55, 41 Number Analyzed 47 participants 48 participants 55 participants 41 participants
46
  97.9%
42
  87.5%
52
  94.5%
37
  90.2%
Week 36; n=46, 48, 50, 41 Number Analyzed 46 participants 48 participants 50 participants 41 participants
40
  87.0%
43
  89.6%
48
  96.0%
36
  87.8%
Week 40; n=38, 35, 45, 39 Number Analyzed 38 participants 35 participants 45 participants 39 participants
33
  86.8%
30
  85.7%
41
  91.1%
34
  87.2%
Week 48; n=33, 37, 45, 35 Number Analyzed 33 participants 37 participants 45 participants 35 participants
32
  97.0%
33
  89.2%
41
  91.1%
33
  94.3%
Week 60; n=38, 38, 40, 37 Number Analyzed 38 participants 38 participants 40 participants 37 participants
37
  97.4%
35
  92.1%
37
  92.5%
35
  94.6%
Week 72; n=35, 37, 44, 32 Number Analyzed 35 participants 37 participants 44 participants 32 participants
32
  91.4%
35
  94.6%
41
  93.2%
27
  84.4%
Week 84; n=36, 39, 42, 33 Number Analyzed 36 participants 39 participants 42 participants 33 participants
34
  94.4%
36
  92.3%
39
  92.9%
29
  87.9%
Week 96; n=31, 36, 33, 0 Number Analyzed 31 participants 36 participants 33 participants 0 participants
25
  80.6%
32
  88.9%
30
  90.9%
Week 108; n=23, 23, 29, 0 Number Analyzed 23 participants 23 participants 29 participants 0 participants
21
  91.3%
20
  87.0%
27
  93.1%
Week 120; n=30, 38, 41, 0 Number Analyzed 30 participants 38 participants 41 participants 0 participants
28
  93.3%
36
  94.7%
39
  95.1%
Week 132; n=29, 32, 40, 0 Number Analyzed 29 participants 32 participants 40 participants 0 participants
28
  96.6%
30
  93.8%
35
  87.5%
Week 144; n=33, 34, 43, 0 Number Analyzed 33 participants 34 participants 43 participants 0 participants
32
  97.0%
29
  85.3%
41
  95.3%
Week 156; n=31, 28, 39, 0 Number Analyzed 31 participants 28 participants 39 participants 0 participants
30
  96.8%
25
  89.3%
35
  89.7%
Week 168; n=29, 33, 41, 0 Number Analyzed 29 participants 33 participants 41 participants 0 participants
29
 100.0%
24
  72.7%
35
  85.4%
Week 180; n=26, 29, 39, 0 Number Analyzed 26 participants 29 participants 39 participants 0 participants
24
  92.3%
24
  82.8%
34
  87.2%
Week 192; n=30, 30, 39, 0 Number Analyzed 30 participants 30 participants 39 participants 0 participants
28
  93.3%
27
  90.0%
35
  89.7%
Week 204; n=29, 32, 38, 0 Number Analyzed 29 participants 32 participants 38 participants 0 participants
27
  93.1%
26
  81.3%
33
  86.8%
Week 216; n=29, 30, 37, 0 Number Analyzed 29 participants 30 participants 37 participants 0 participants
29
 100.0%
27
  90.0%
31
  83.8%
Week 228; n=27, 34, 40, 0 Number Analyzed 27 participants 34 participants 40 participants 0 participants
25
  92.6%
28
  82.4%
35
  87.5%
Week 240; n=28, 26, 41, 0 Number Analyzed 28 participants 26 participants 41 participants 0 participants
28
 100.0%
22
  84.6%
35
  85.4%
Week 252; n=23, 26, 33, 0 Number Analyzed 23 participants 26 participants 33 participants 0 participants
18
  78.3%
21
  80.8%
29
  87.9%
Week 264; n=15, 18, 24, 0 Number Analyzed 15 participants 18 participants 24 participants 0 participants
12
  80.0%
16
  88.9%
21
  87.5%
Week 276; n=14, 14, 21, 0 Number Analyzed 14 participants 14 participants 21 participants 0 participants
13
  92.9%
13
  92.9%
18
  85.7%
Week 288; n=12, 14, 18, 0 Number Analyzed 12 participants 14 participants 18 participants 0 participants
12
 100.0%
10
  71.4%
17
  94.4%
Week 300; n=12, 13, 20, 0 Number Analyzed 12 participants 13 participants 20 participants 0 participants
11
  91.7%
7
  53.8%
18
  90.0%
Week 312; n=1, 1, 0, 0 Number Analyzed 1 participants 1 participants 0 participants 0 participants
1
 100.0%
1
 100.0%
14.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 16 and Week 24 Using MSDF Algorithm-Induction Phase
Hide Description Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population.
Time Frame Week 16 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title GSK1265744 10 mg GSK1265744 30 mg GSK1265744 60 mg Efavirenz 600 mg
Hide Arm/Group Description:
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Overall Number of Participants Analyzed 60 60 61 62
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 16
90
(82 to 98)
83
(74 to 93)
87
(78 to 95)
74
(63 to 85)
Week 24
87
(78 to 95)
85
(76 to 94)
87
(78 to 95)
74
(63 to 85)
15.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase
Hide Description Plasma samples were collected for quantitative analysis of HIV-1 RNA. The end point was determined using MSDF algorithm based on the current US FDA definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-Maintenance Exposed (ME) Population comprised of all participants randomized to GSK1265744 and who received at least one dose of investigational product during maintenance phase of the study.
Time Frame Weeks 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-ME Population
Arm/Group Title GSK1265744 10 mg GSK1265744 30 mg GSK1265744 60 mg Efavirenz 600 mg
Hide Arm/Group Description:
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Overall Number of Participants Analyzed 52 53 55 47
Measure Type: Number
Unit of Measure: Percentage of participants
Week 24 96 94 96 96
Week 26 90 85 95 87
Week 28 98 89 95 91
Week 32 96 91 96 91
Week 36 98 92 95 94
Week 40 96 92 95 89
Week 48 92 91 96 94
Week 60 90 83 95 89
Week 72 83 83 95 89
Week 84 83 85 95 89
Week 96 79 85 93 83
16.Secondary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Maintenance Phase
Hide Description An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Maintenance Safety Population comprised of all participants randomized to GSK1265744 and who were exposed to investigational products during the maintenance phase of the study with the exception of any participants with documented evidence of not having consumed any amount of investigational product.
Time Frame Week 24 to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Maintenance Safety Population
Arm/Group Title GSK1265744 10 mg GSK1265744 30 mg GSK1265744 60 mg Efavirenz 600 mg
Hide Arm/Group Description:
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Overall Number of Participants Analyzed 52 53 55 47
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE
40
  76.9%
50
  94.3%
50
  90.9%
35
  74.5%
Any SAE
5
   9.6%
5
   9.4%
5
   9.1%
2
   4.3%
17.Secondary Outcome
Title Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase
Hide Description Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotranferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), carbon dioxide(CO2)/bicarbonate, cholesterol, creatine kinase (CK), creatinine, glucose, low density lipoprotein (LDL) cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin and triglycerides. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
Time Frame Week 24 to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Maintenance Safety Population
Arm/Group Title GSK1265744 10 mg GSK1265744 30 mg GSK1265744 60 mg Efavirenz 600 mg
Hide Arm/Group Description:
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Overall Number of Participants Analyzed 52 53 55 47
Measure Type: Count of Participants
Unit of Measure: Participants
ALT; Grade 1
9
  17.3%
12
  22.6%
17
  30.9%
6
  12.8%
ALT; Grade 2
6
  11.5%
6
  11.3%
5
   9.1%
3
   6.4%
ALT; Grade 3
0
   0.0%
1
   1.9%
0
   0.0%
0
   0.0%
ALT; Grade 4
1
   1.9%
1
   1.9%
0
   0.0%
1
   2.1%
Albumin; Grade 1
0
   0.0%
1
   1.9%
0
   0.0%
0
   0.0%
Albumin; Grade 2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Albumin; Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Albumin; Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALP; Grade 1
2
   3.8%
1
   1.9%
4
   7.3%
4
   8.5%
ALP; Grade 2
0
   0.0%
1
   1.9%
0
   0.0%
0
   0.0%
ALP; Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALP; Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
AST; Grade 1
5
   9.6%
13
  24.5%
13
  23.6%
5
  10.6%
AST; Grade 2
5
   9.6%
8
  15.1%
5
   9.1%
2
   4.3%
AST; Grade 3
2
   3.8%
0
   0.0%
2
   3.6%
3
   6.4%
AST; Grade 4
2
   3.8%
1
   1.9%
0
   0.0%
2
   4.3%
CO2/bicarbonate; Grade 1
6
  11.5%
14
  26.4%
9
  16.4%
8
  17.0%
CO2/bicarbonate; Grade 2
1
   1.9%
0
   0.0%
0
   0.0%
1
   2.1%
CO2/bicarbonate; Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
CO2/bicarbonate; Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Cholesterol; Grade 1
17
  32.7%
17
  32.1%
19
  34.5%
9
  19.1%
Cholesterol; Grade 2
6
  11.5%
12
  22.6%
15
  27.3%
10
  21.3%
Cholesterol; Grade 3
3
   5.8%
0
   0.0%
3
   5.5%
4
   8.5%
Cholesterol; Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
CK; Grade 1
8
  15.4%
9
  17.0%
11
  20.0%
5
  10.6%
CK; Grade 2
2
   3.8%
4
   7.5%
4
   7.3%
0
   0.0%
CK; Grade 3
3
   5.8%
2
   3.8%
4
   7.3%
3
   6.4%
CK; Grade 4
6
  11.5%
6
  11.3%
5
   9.1%
5
  10.6%
Creatinine; Grade 1
1
   1.9%
1
   1.9%
2
   3.6%
1
   2.1%
Creatinine; Grade 2
1
   1.9%
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine; Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine; Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Glucose; Grade 1
17
  32.7%
17
  32.1%
20
  36.4%
11
  23.4%
Glucose; Grade 2
14
  26.9%
10
  18.9%
11
  20.0%
5
  10.6%
Glucose; Grade 3
0
   0.0%
0
   0.0%
2
   3.6%
0
   0.0%
Glucose; Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
LDL cholesterol; Grade 1
14
  26.9%
16
  30.2%
13
  23.6%
8
  17.0%
LDL cholesterol; Grade 2
6
  11.5%
11
  20.8%
14
  25.5%
6
  12.8%
LDL cholesterol; Grade 3
4
   7.7%
2
   3.8%
7
  12.7%
4
   8.5%
LDL cholesterol; Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lipase; Grade 1
9
  17.3%
9
  17.0%
8
  14.5%
9
  19.1%
Lipase; Grade 2
9
  17.3%
8
  15.1%
11
  20.0%
7
  14.9%
Lipase; Grade 3
5
   9.6%
1
   1.9%
6
  10.9%
0
   0.0%
Lipase; Grade 4
2
   3.8%
0
   0.0%
2
   3.6%
0
   0.0%
Inorganic phosphorus; Grade 1
5
   9.6%
3
   5.7%
9
  16.4%
7
  14.9%
Inorganic phosphorus; Grade 2
10
  19.2%
11
  20.8%
5
   9.1%
9
  19.1%
Inorganic phosphorus; Grade 3
2
   3.8%
1
   1.9%
5
   9.1%
2
   4.3%
Inorganic phosphorus; Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potassium; Grade 1
12
  23.1%
7
  13.2%
8
  14.5%
4
   8.5%
Potassium; Grade 2
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.1%
Potassium; Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potassium; Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sodium; Grade 1
14
  26.9%
12
  22.6%
16
  29.1%
7
  14.9%
Sodium; Grade 2
2
   3.8%
1
   1.9%
0
   0.0%
1
   2.1%
Sodium; Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sodium; Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Total bilirubin; Grade 1
7
  13.5%
1
   1.9%
8
  14.5%
0
   0.0%
Total bilirubin; Grade 2
2
   3.8%
3
   5.7%
4
   7.3%
0
   0.0%
Total bilirubin; Grade 3
0
   0.0%
1
   1.9%
0
   0.0%
0
   0.0%
Total bilirubin; Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Triglycerides; Grade 1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Triglycerides; Grade 2
1
   1.9%
4
   7.5%
3
   5.5%
1
   2.1%
Triglycerides; Grade 3
1
   1.9%
0
   0.0%
3
   5.5%
1
   2.1%
Triglycerides; Grade 4
0
   0.0%
0
   0.0%
1
   1.8%
0
   0.0%
18.Secondary Outcome
Title Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase
Hide Description Blood samples were collected for the analysis of following hematology parameters: Activated Partial Thromboplastin Time (APTT), hemoglobin, international normalized ratio (INR), platelet count, prothrombin time (PT), total neutrophils and white blood cell (WBC) count. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
Time Frame Week 24 to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Maintenance Safety Population
Arm/Group Title GSK1265744 10 mg GSK1265744 30 mg GSK1265744 60 mg Efavirenz 600 mg
Hide Arm/Group Description:
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Overall Number of Participants Analyzed 52 53 55 47
Measure Type: Count of Participants
Unit of Measure: Participants
APTT; Grade 1
5
   9.6%
5
   9.4%
5
   9.1%
5
  10.6%
APTT; Grade 2
0
   0.0%
1
   1.9%
0
   0.0%
0
   0.0%
APTT; Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
APTT; Grade 4
1
   1.9%
1
   1.9%
1
   1.8%
1
   2.1%
Hemoglobin; Grade 1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hemoglobin; Grade 2
1
   1.9%
0
   0.0%
0
   0.0%
0
   0.0%
Hemoglobin; Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hemoglobin; Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
INR; Grade 1
2
   3.8%
4
   7.5%
0
   0.0%
3
   6.4%
INR; Grade 2
0
   0.0%
1
   1.9%
1
   1.8%
1
   2.1%
INR; Grade 3
1
   1.9%
0
   0.0%
0
   0.0%
0
   0.0%
INR; Grade 4
0
   0.0%
1
   1.9%
0
   0.0%
0
   0.0%
Platelet count; Grade 1
4
   7.7%
0
   0.0%
4
   7.3%
1
   2.1%
Platelet count; Grade 2
0
   0.0%
0
   0.0%
1
   1.8%
0
   0.0%
Platelet count; Grade 3
0
   0.0%
0
   0.0%
1
   1.8%
0
   0.0%
Platelet count; Grade 4
0
   0.0%
0
   0.0%
1
   1.8%
0
   0.0%
PT; Grade 1
1
   1.9%
3
   5.7%
0
   0.0%
3
   6.4%
PT; Grade 2
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.1%
PT; Grade 3
0
   0.0%
1
   1.9%
1
   1.8%
0
   0.0%
PT; Grade 4
0
   0.0%
1
   1.9%
0
   0.0%
0
   0.0%
Total neutrophils; Grade 1
7
  13.5%
9
  17.0%
10
  18.2%
2
   4.3%
Total neutrophils; Grade 2
5
   9.6%
2
   3.8%
3
   5.5%
3
   6.4%
Total neutrophils; Grade 3
1
   1.9%
0
   0.0%
1
   1.8%
1
   2.1%
Total neutrophils; Grade 4
1
   1.9%
1
   1.9%
3
   5.5%
1
   2.1%
WBC count; Grade 1
2
   3.8%
5
   9.4%
2
   3.6%
3
   6.4%
WBC count; Grade 2
1
   1.9%
1
   1.9%
1
   1.8%
0
   0.0%
WBC count; Grade 3
0
   0.0%
0
   0.0%
1
   1.8%
0
   0.0%
WBC count; Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
19.Secondary Outcome
Title Number of Participants With AEs and SAEs Over Time
Hide Description An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Safety Population comprised of all randomized participants who were exposed to investigational products with the exception of any participants with documented evidence of not having consumed any amount of investigational product.
Time Frame Up to Week 324
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title GSK1265744 10 mg GSK1265744 30 mg GSK1265744 60 mg Efavirenz 600 mg
Hide Arm/Group Description:
Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.
Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Overall Number of Participants Analyzed 60 60 61 62
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE
57
  95.0%
57
  95.0%
60
  98.4%
60
  96.8%
Any SAE
13
  21.7%
12
  20.0%
11
  18.0%
4
   6.5%