Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Assessing Dolutegravir in HIV-1 Infected Subjects With Virus Resistant to Raltegravir and/or Elivitegravir (VIKING-4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01568892
Recruitment Status : Completed
First Posted : April 2, 2012
Results First Posted : February 19, 2014
Last Update Posted : July 2, 2018
Sponsor:
Collaborators:
Shionogi
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: Dolutegravir 50 mg twice daily
Drug: Dolutegravir placebo twice daily
Enrollment 30
Recruitment Details  
Pre-assignment Details Participants (par.) meeting eligibility criteria at screening entered a 7-day randomized, double-blind, placebo-controlled phase. At Day 8, all par. entered an open-label phase and continued to receive dolutegravir with an optimized background regimen. A total of 75 par. were screened; 45 par. were screen failures, and 30 par. were randomized.
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase. Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Period Title: Double-blind Phase
Started 14 16
Completed 14 16
Not Completed 0 0
Period Title: Open-label Phase
Started 13 [1] 16
Completed 7 13
Not Completed 6 3
Reason Not Completed
Adverse Event             2             0
Lack of Efficacy             4             2
Lost to Follow-up             0             1
[1]
One participant completing the DB Phase withdrew on Day 8 and did not enter the Open-label Phase.
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase Total
Hide Arm/Group Description Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase. Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase. Total of all reporting groups
Overall Number of Baseline Participants 14 16 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 16 participants 30 participants
47.5  (11.56) 48.6  (8.85) 48.1  (10.04)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 16 participants 30 participants
Female
2
  14.3%
4
  25.0%
6
  20.0%
Male
12
  85.7%
12
  75.0%
24
  80.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 16 participants 30 participants
African American/African Heritage
8
  57.1%
8
  50.0%
16
  53.3%
American Indian or Alaska Native
0
   0.0%
1
   6.3%
1
   3.3%
White - Arabic/North African Heritage
1
   7.1%
0
   0.0%
1
   3.3%
White - White/Caucasian/European Heritage
4
  28.6%
7
  43.8%
11
  36.7%
Missing: None of the Available Races Applied
1
   7.1%
0
   0.0%
1
   3.3%
1.Primary Outcome
Title Mean Change From Baseline in Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) at Day 8
Hide Description Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1) and Day 8. Change from Baseline was calculated as the value at Day 8 minus the value at Baseline (Day 1). The analysis was performed using statistical modeling correcting for Baseline plasma HIV-1 RNA, Baseline Dolutegravir (DTG) fold change (FC), the overall susceptibility score (OSS) of the failing regimen, and the interaction between DTG FC and treatment. Means and differences were calculated using the average Baseline DTG FC of the entire Intent-to-Treat Exposed (ITT-E) Population. The last observation carried forward with discontinuation equals Baseline (LOCFDB) dataset was used for the analysis. For the LOCFDB dataset, missing values were carried forward from the previous, non-missing, available on-treatment assessment, except formissing values due to premature withdrawal or Day 8 missing values, which had the Baseline value imputed.
Time Frame Baseline and Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population: all randomized participants who received at least one dose of study medication. One participant receiving DTG 50 mg BID was excluded from analysis because they had no Baseline DTG FC value.
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Overall Number of Participants Analyzed 13 16
Least Squares Mean (Standard Error)
Unit of Measure: Log 10 copies per milliliter (c/mL)
-1.06  (0.168) 0.10  (0.183)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG 50 mg BID, Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.16
Confidence Interval (2-Sided) 95%
-1.52 to -0.80
Estimation Comments The estimated value represents the adjusted mean difference between the two treatment arms.
2.Secondary Outcome
Title Absolute Values in Plasma HIV-1 RNA Over Time
Hide Description Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Day 8, Day 28, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, and Week 84. NA indicates data was not available.
Time Frame Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Overall Number of Participants Analyzed 14 16
Mean (Standard Deviation)
Unit of Measure: Log10 c/mL
Baseline, n=14, 16 Number Analyzed 14 participants 16 participants
4.02  (0.940) 4.42  (0.760)
Day 8, n=14, 16 Number Analyzed 14 participants 16 participants
2.95  (0.790) 4.39  (0.844)
Day 28, n=13, 16 Number Analyzed 13 participants 16 participants
2.14  (0.772) 2.30  (1.054)
Week 8, n=11, 16 Number Analyzed 11 participants 16 participants
2.35  (0.851) 2.10  (0.913)
Week 12, n=12, 14 Number Analyzed 12 participants 14 participants
2.51  (1.048) 2.27  (1.179)
Week 16, n=12, 16 Number Analyzed 12 participants 16 participants
2.57  (1.093) 2.18  (1.098)
Week 24, n=11, 15 Number Analyzed 11 participants 15 participants
2.65  (1.219) 1.88  (0.654)
Week 32, n=11, 14 Number Analyzed 11 participants 14 participants
2.72  (1.176) 1.81  (0.664)
Week 40, n=7, 12 Number Analyzed 7 participants 12 participants
2.35  (1.169) 1.68  (0.133)
Week 48, n=8, 13 Number Analyzed 8 participants 13 participants
2.47  (1.037) 1.62  (0.088)
Week 60, n=5, 12 Number Analyzed 5 participants 12 participants
2.15  (1.013) 1.67  (0.150)
Week 72, n=3, 4 Number Analyzed 3 participants 4 participants
2.35  (1.312) 1.62  (0.054)
Week 84, n=0, 1 Number Analyzed 0 participants 1 participants
1.59 [1]   (NA)
[1]
Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.
3.Secondary Outcome
Title Mean Change From Baseline in Plasma HIV-1 RNA Over Time
Hide Description Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Day 8, Day 28, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, and Week 84. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.
Time Frame Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. The Observed Case dataset, in which only the data that are available at the particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Overall Number of Participants Analyzed 14 16
Mean (Standard Deviation)
Unit of Measure: Log10 c/mL
Baseline, n=14, 16 Number Analyzed 14 participants 16 participants
4.02  (0.940) 4.42  (0.760)
Day 8, n=14, 16 Number Analyzed 14 participants 16 participants
-1.07  (0.683) -0.03  (0.262)
Day 28, n=13, 16 Number Analyzed 13 participants 16 participants
-1.87  (0.898) -2.12  (1.111)
Week 8, n=11, 16 Number Analyzed 11 participants 16 participants
-1.89  (0.890) -2.32  (1.112)
Week 12, n=12, 14 Number Analyzed 12 participants 14 participants
-1.54  (1.022) -2.02  (1.245)
Week 16, n=12, 16 Number Analyzed 12 participants 16 participants
-1.48  (1.101) -2.24  (1.180)
Week 24, n=11, 15 Number Analyzed 11 participants 15 participants
-1.38  (1.151) -2.53  (1.033)
Week 32, n=11, 14 Number Analyzed 11 participants 14 participants
-1.31  (1.059) -2.62  (0.931)
Week 40, n=7, 12 Number Analyzed 7 participants 12 participants
-1.48  (1.445) -2.70  (0.843)
Week 48, n=8, 13 Number Analyzed 8 participants 13 participants
-1.34  (1.235) -2.77  (0.881)
Week 60, n=5, 12 Number Analyzed 5 participants 12 participants
-1.91  (1.400) -2.71  (0.863)
Week 72, n=3, 4 Number Analyzed 3 participants 4 participants
-2.08  (1.311) -3.31  (0.968)
Week 84, n=0, 1 Number Analyzed 0 participants 1 participants
-3.75 [1]   (NA)
[1]
Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.
4.Secondary Outcome
Title Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time
Hide Description Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1); Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, and 48. Number of participants with plasma HIV-1 RNA level <50 c/mL was obtained using Food and Drug Administration's (FDA's) snapshot algorithm, where all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) were treated as non-responders. Also, participants who switched their concomitant antiretroviral therapy (ART) prior to the visit of interest as follows were also treated as non-responders: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol; however, the decision to switch is not documented as being before or at the first On-treatment visit after switching to optimized background regimen (OBR) (i.e. Day 28) where HIV-1 RNA is assessed.
Time Frame Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. The Snapshot dataset was used for analysis.
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Overall Number of Participants Analyzed 14 16
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline
0
   0.0%
0
   0.0%
Day 8
1
   7.1%
0
   0.0%
Day 28
6
  42.9%
6
  37.5%
Week 8
5
  35.7%
9
  56.3%
Week 12
6
  42.9%
8
  50.0%
Week 16
5
  35.7%
8
  50.0%
Week 24
6
  42.9%
8
  50.0%
Week 32
4
  28.6%
9
  56.3%
Week 40
4
  28.6%
7
  43.8%
Week 48
3
  21.4%
9
  56.3%
5.Secondary Outcome
Title Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time
Hide Description Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1); Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40 and 48. Number of participants with plasma HIV-1 RNA level <400 c/mL was obtained using FDA's snapshot algorithm, where all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) were treated as non-responders. Also, participants who switch their concomitant ART prior to the visit of interest as follows were also treated as non-responders: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol; however the decision to switch is not documented as being before or at the first On-treatment visit after switching to OBR (i.e. Day 28) where HIV-1 RNA is assessed.
Time Frame Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. The Snapshot dataset was used for analysis.
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Overall Number of Participants Analyzed 14 16
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline
2
  14.3%
0
   0.0%
Day 8
4
  28.6%
0
   0.0%
Day 28
9
  64.3%
12
  75.0%
Week 8
7
  50.0%
13
  81.3%
Week 12
7
  50.0%
10
  62.5%
Week 16
7
  50.0%
12
  75.0%
Week 24
6
  42.9%
11
  68.8%
Week 32
6
  42.9%
10
  62.5%
Week 40
5
  35.7%
10
  62.5%
Week 48
6
  42.9%
10
  62.5%
6.Secondary Outcome
Title Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time
Hide Description Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84.
Time Frame Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Overall Number of Participants Analyzed 14 16
Median (Inter-Quartile Range)
Unit of Measure: Cells per cubic millimeters
Baseline, n=14, 16 Number Analyzed 14 participants 16 participants
163.5
(111.0 to 231.0)
90.5
(46.0 to 267.5)
Day 8, n=14, 15 Number Analyzed 14 participants 15 participants
198.5
(154.0 to 239.0)
102.0
(50.0 to 310.0)
Day 28, n=13, 16 Number Analyzed 13 participants 16 participants
174.0
(168.0 to 335.0)
234.0
(114.5 to 303.5)
Week 8, n=11, 16 Number Analyzed 11 participants 16 participants
211.0
(71.0 to 401.0)
228.0
(124.0 to 357.5)
Week 12, n=12, 14 Number Analyzed 12 participants 14 participants
223.5
(115.0 to 345.5)
217.5
(121.0 to 333.0)
Week 16, n=12, 16 Number Analyzed 12 participants 16 participants
241.0
(107.5 to 382.5)
262.5
(132.5 to 436.5)
Week 24, n=11, 15 Number Analyzed 11 participants 15 participants
232.0
(116.0 to 509.0)
242.0
(194.0 to 399.0)
Week 32, n=11, 14 Number Analyzed 11 participants 14 participants
213.0
(91.0 to 489.0)
326.0
(229.0 to 542.0)
Week 40, n=8, 12 Number Analyzed 8 participants 12 participants
299.5
(212.5 to 566.5)
328.0
(204.5 to 508.0)
Week 48, n=8, 13 Number Analyzed 8 participants 13 participants
328.0
(263.0 to 526.5)
370.0
(231.0 to 457.0)
Week 60, n=5, 12 Number Analyzed 5 participants 12 participants
321.0
(234.0 to 328.0)
333.0
(217.5 to 541.0)
Week 72, n=3, 4 Number Analyzed 3 participants 4 participants
321.0
(261.0 to 465.0)
299.5
(231.5 to 349.0)
Week 84, n=0, 1 Number Analyzed 0 participants 1 participants
368.0
(368.0 to 368.0)
7.Secondary Outcome
Title Median Change From Baseline in CD4+ Cell Counts Over Time
Hide Description Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.
Time Frame Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Observed dataset was used for analysis. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Overall Number of Participants Analyzed 14 16
Median (Inter-Quartile Range)
Unit of Measure: Cells per cubic millimeters
Baseline, n=14, 16 Number Analyzed 14 participants 16 participants
163.5
(111.0 to 231.0)
90.5
(46.0 to 267.5)
Day 8, n=14, 15 Number Analyzed 14 participants 15 participants
7.0
(0.0 to 94.0)
0.0
(-12.0 to 24.0)
Day 28, n=13, 16 Number Analyzed 13 participants 16 participants
14.0
(6.0 to 68.0)
68.5
(5.0 to 140.5)
Week 8, n=11, 16 Number Analyzed 11 participants 16 participants
34.0
(10.0 to 96.0)
87.5
(9.5 to 138.5)
Week 12, n=12, 14 Number Analyzed 12 participants 14 participants
49.0
(-5.0 to 83.0)
79.0
(1.0 to 121.0)
Week 16, n=12, 16 Number Analyzed 12 participants 16 participants
76.5
(3.0 to 151.0)
70.0
(20.5 to 235.0)
Week 24, n=11, 15 Number Analyzed 11 participants 15 participants
39.0
(0.0 to 134.0)
117.0
(23.0 to 163.0)
Week 32, n=11, 14 Number Analyzed 11 participants 14 participants
48.0
(0.0 to 198.0)
135.5
(58.0 to 271.0)
Week 40, n=8, 12 Number Analyzed 8 participants 12 participants
90.5
(45.0 to 226.5)
125.5
(50.0 to 244.5)
Week 48, n=8, 13 Number Analyzed 8 participants 13 participants
115.0
(96.0 to 226.5)
156.0
(68.0 to 293.0)
Week 60, n=5, 12 Number Analyzed 5 participants 12 participants
170.0
(65.0 to 210.0)
146.0
(73.5 to 242.0)
Week 72, n=3, 4 Number Analyzed 3 participants 4 participants
163.0
(96.0 to 354.0)
174.0
(147.0 to 225.0)
Week 84, n=0, 1 Number Analyzed 0 participants 1 participants
269.0
(269.0 to 269.0)
8.Secondary Outcome
Title Absolute Values in Cluster of Differentiation 8+ (CD8+) Cell Counts Over Time
Hide Description Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline; Day 28; and Weeks 12, 24, and 48.
Time Frame Baseline; Day 28; Weeks 12, 24, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Overall Number of Participants Analyzed 14 16
Median (Inter-Quartile Range)
Unit of Measure: Cells per cubic millimeter
Baseline, n=14, 16 Number Analyzed 14 participants 16 participants
896.0
(589.0 to 1689.0)
808.5
(436.5 to 1221.0)
Day 28, n=13, 16 Number Analyzed 13 participants 16 participants
1135.0
(598.0 to 1741.0)
973.0
(675.0 to 1322.0)
Week 12, n=11, 14 Number Analyzed 11 participants 14 participants
1198.0
(591.0 to 1977.0)
1184.0
(860.0 to 1711.0)
Week 24, n=11, 15 Number Analyzed 11 participants 15 participants
1160.0
(526.0 to 1908.0)
1323.0
(969.0 to 1622.0)
Week 48, n=6, 12 Number Analyzed 6 participants 12 participants
1295.0
(837.0 to 1818.0)
1147.0
(753.0 to 1570.0)
9.Secondary Outcome
Title Median Change From Baseline in CD8+ Cell Counts Over Time
Hide Description Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline; Day 28; and Weeks 12, 24, and 48. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.
Time Frame Baseline; Day 28; Weeks 12, 24, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Overall Number of Participants Analyzed 14 16
Median (Inter-Quartile Range)
Unit of Measure: Cells per cubic millimeter
Baseline, n=14, 16 Number Analyzed 14 participants 16 participants
896.0
(589.0 to 1689.0)
808.5
(436.5 to 1221.0)
Day 28, n=13, 16 Number Analyzed 13 participants 16 participants
227.0
(-135.0 to 301.0)
177.0
(51.0 to 278.5)
Week 12, n=11, 14 Number Analyzed 11 participants 14 participants
151.0
(-150.0 to 379.0)
288.0
(193.0 to 484.0)
Week 24, n=11, 15 Number Analyzed 11 participants 15 participants
79.0
(-183.0 to 269.0)
543.0
(35.0 to 930.0)
Week 48, n=6, 12 Number Analyzed 6 participants 12 participants
88.0
(-19.0 to 179.0)
124.0
(-102.5 to 238.5)
10.Secondary Outcome
Title Number of Participants With the Indicated Type of HIV-1 Disease Progression (Acquired Immunodeficiency Syndrome [AIDS] or Death [DT])
Hide Description The number of participants with HIV-1 disease progression (AIDS or death) was assessed per the Centers for Disease Control and Prevention (CDC) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).
Time Frame From the day of the first dose of study drug until early withdrawal or the Week 48 analysis cut-off date (median of 55 study weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Overall Number of Participants Analyzed 14 16
Measure Type: Count of Participants
Unit of Measure: Participants
From CDC Class A to CDC Class C
0
   0.0%
0
   0.0%
From CDC Class B to CDC Class C
0
   0.0%
0
   0.0%
From CDC Class C to new CDC Class C
0
   0.0%
0
   0.0%
From CDC Class A, B, or C to Death
2
  14.3%
0
   0.0%
11.Secondary Outcome
Title Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Grade
Hide Description An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as 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; or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in other situations. Adverse events were graded for severity according to the Division of AIDS (DAIDS) toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).
Time Frame From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all randomized participants who received at least one dose of study medication
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Overall Number of Participants Analyzed 14 16
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
0
   0.0%
4
  25.0%
Grade 2
7
  50.0%
6
  37.5%
Grade 3
2
  14.3%
3
  18.8%
Grade 4
2
  14.3%
1
   6.3%
12.Secondary Outcome
Title Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade
Hide Description Participants with post-Baseline-emergent clinical chemistry toxicities were analyzed. Clinical chemistry toxicities were graded for severity according to the DAIDS toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).
Time Frame From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Overall Number of Participants Analyzed 14 16
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
5
  35.7%
4
  25.0%
Grade 2
5
  35.7%
5
  31.3%
Grade 3
0
   0.0%
4
  25.0%
Grade 4
0
   0.0%
1
   6.3%
13.Secondary Outcome
Title Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade
Hide Description Participants with post-Baseline-emergent hematology toxicities were analyzed. Hematology toxicities were graded for severity according to the DAIDS toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).
Time Frame From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Overall Number of Participants Analyzed 14 16
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
2
  14.3%
3
  18.8%
Grade 2
2
  14.3%
5
  31.3%
Grade 3
0
   0.0%
1
   6.3%
Grade 4
0
   0.0%
0
   0.0%
14.Secondary Outcome
Title AUC(0-tau) of DTG
Hide Description The area under the time concentration curve over the dosing interval (AUC[0-tau]) of DTG was assessed by a population pharmacokinetic (PK) modeling approach using pooled DTG PK data from multiple studies. Blood samples for the determination of plasma DTG concentration were collected at the following time points: pre-dose and 1-3 hours post-dose on Day 8; pre-dose and within a post-dose window (1-3 hours or 4-12 hours) on Day 28 and Week 24. For Day 8 PK, only samples collected from participants randomized to the active DTG arm were analyzed.
Time Frame Day 8, Day 28, and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
PK concentration Population comprised of all participants who received DTG, underwent PK sampling during the study, and provided evaluable DTG plasma concentration data.
Arm/Group Title Overall Study Arm
Hide Arm/Group Description:
All the participants who received DTG 50 mg BID.
Overall Number of Participants Analyzed 29
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg*hour per mL (µg*hr/mL)
37.9
(41.8%)
15.Secondary Outcome
Title Cmax of DTG
Hide Description The maximal concentration (Cmax) of DTG was assessed by a population PK modeling approach using pooled DTG PK data from multiple studies. Blood samples for the determination of plasma DTG concentration were collected at the following time points: pre-dose and 1-3 hours post-dose on Day 8; pre-dose and within a post-dose window (1-3 hours or 4-12 hours) on Day 28 and Week 24. For Day 8 PK, only samples collected from participants randomized to the active DTG arm were analyzed.
Time Frame Day 8, Day 28, and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
PK concentration Population comprised of all participants who received DTG, underwent PK sampling during the study, and provided evaluable DTG plasma concentration data.
Arm/Group Title Overall Study Arm
Hide Arm/Group Description:
All the participants who received DTG 50 mg BID.
Overall Number of Participants Analyzed 29
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Micrograms per milliliter (µg/mL)
4.14
(32.6%)
16.Secondary Outcome
Title Plasma DTG Pre-dose Concentration (C0) at Day 8, Day 28, and Week 24; and Average DTG C0 (C0 Avg) at Week 24
Hide Description Blood samples for the determination of plasma DTG pre-dose concentration were collected pre-dose on Day 8, Day 28, and Week 24. For Day 8 PK, only samples collected from participants randomized to the active DTG arm were analyzed. C0 Avg was calculated at Week 24 as the mean of the concentration at Day 8, Day 28, and Week 24.
Time Frame Day 8, Day 28, and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Parameter Population.
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Overall Number of Participants Analyzed 13 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
Day 8 C0, n=10, 0 Number Analyzed 10 participants 0 participants
3.043
(44%)
Day 28 C0, n=11, 16 Number Analyzed 11 participants 16 participants
1.393
(189%)
2.154
(81%)
Week 24 C0, n=10, 14 Number Analyzed 10 participants 14 participants
1.864
(110%)
2.201
(145%)
C0_avg, n=13, 16 Number Analyzed 13 participants 16 participants
1.820
(188%)
2.307
(76%)
17.Secondary Outcome
Title Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance
Hide Description For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Day 28, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >1 log10 copies/mL above the nadir value, where nadir is >=400 copies/mL.Treatment-emergent IN mutations are those detected at the time of PDVF but not at Baseline.
Time Frame From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
PDVF Genotypic/Phenotypic Population: all participants in the ITT-E population with protocol-defined virologic failure. Only participants with Baseline integrase mutations with PDVF who had paired Baseline and time of PDVF samples were considered for analysis.
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Overall Number of Participants Analyzed 5 2
Measure Type: Count of Participants
Unit of Measure: Participants
Any integrase mutation
4
  80.0%
1
  50.0%
L74L/M
1
  20.0%
0
   0.0%
T97A
2
  40.0%
1
  50.0%
E138E/K
1
  20.0%
0
   0.0%
E138K
1
  20.0%
0
   0.0%
S147G
1
  20.0%
0
   0.0%
N155N/H
1
  20.0%
0
   0.0%
18.Secondary Outcome
Title Number of Participants With the Indicated Fold Increase in Fold Change (FC) in the 50% Inhibitory Concentration Relative to Wild-type Virus for DTG (i.e. PDVF FC/Baseline FC Ratio) at the Time of PDVF, as a Measure of Phenotypic Resistance
Hide Description For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. The FC in IC50 (50% inhibitory concentration) for DTG relative to wild-type virus was determined for virus isolated at Baseline and at the time of PDVF. The number of participants with the indicated change (ratio) in the two values at the time of PDVF is presented. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Day 28, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >1 log10 copies/mL above the nadir value, where nadir is >=400 copies/mL.
Time Frame From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
PDVF Genotypic/Phenotypic Population: all participants in the ITT-E population with protocol-defined virologic failure. Only participants with Baseline integrase mutations with PDVF who had paired Baseline and time of PDVF samples were considered for analysis.
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Overall Number of Participants Analyzed 5 2
Measure Type: Count of Participants
Unit of Measure: Participants
4-<8 fold increase in DTG FC
0
   0.0%
1
  50.0%
>=8 fold increase in DTG FC
4
  80.0%
0
   0.0%
19.Secondary Outcome
Title Number of Participants Who Discontinued Study Treatment Due to AEs
Hide Description The number of participants who permanently discontinued study treatment due to AEs is presented.
Time Frame From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Overall Number of Participants Analyzed 14 16
Measure Type: Count of Participants
Unit of Measure: Participants
2
  14.3%
0
   0.0%
20.Secondary Outcome
Title Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Hide Description Twelve lead ECG was performed using an automated ECG machine. The number of participants with abnormal-clinically significant ECG findings at any time on-treatment is reported.
Time Frame Up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time point was analyzed.
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Overall Number of Participants Analyzed 12 15
Measure Type: Count of Participants
Unit of Measure: Participants
1
   8.3%
1
   6.7%
21.Secondary Outcome
Title Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Hide Description Vital signs including SBP and DBP were measured at Baseline, Week 24 and Week 48. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.
Time Frame Baseline and Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Overall Number of Participants Analyzed 14 16
Mean (Standard Deviation)
Unit of Measure: millimeters of mercury
SBP; Baseline; n=14, 16 Number Analyzed 14 participants 16 participants
120.4  (15.60) 113.4  (9.99)
SBP; Week 24; n=11, 15 Number Analyzed 11 participants 15 participants
2.0  (12.28) 2.8  (13.82)
SBP; Week 48; n=6, 12 Number Analyzed 6 participants 12 participants
-0.7  (19.50) 3.1  (12.57)
DBP; Baseline; n=14, 16 Number Analyzed 14 participants 16 participants
78.9  (12.51) 75.1  (8.46)
DBP; Week 24; n=11, 15 Number Analyzed 11 participants 15 participants
-0.5  (9.49) -1.2  (10.35)
DBP; Week 48; n=6, 12 Number Analyzed 6 participants 12 participants
-1.2  (13.92) -3.2  (8.78)
22.Secondary Outcome
Title Change From Baseline in Heart Rate
Hide Description Vital signs including heart rate was measured at Baseline, Week 24 and Week 48. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.
Time Frame Baseline and Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Overall Number of Participants Analyzed 14 16
Mean (Standard Deviation)
Unit of Measure: beats per minute
Baseline; n=14, 16 Number Analyzed 14 participants 16 participants
72.5  (9.70) 75.9  (14.56)
Week 24; n=11, 15 Number Analyzed 11 participants 15 participants
-1.4  (8.42) 0.7  (11.20)
Week 48; 6, 12 Number Analyzed 6 participants 12 participants
2.2  (11.03) -2.5  (17.76)
23.Secondary Outcome
Title Change From Baseline in Albumin Level
Hide Description Blood samples were collected for the analysis of clinical chemistry parameters such as albumin. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.
Time Frame Baseline, Week 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Overall Number of Participants Analyzed 14 16
Mean (Standard Deviation)
Unit of Measure: grams per liter
Albumin; Baseline; n=14, 16 Number Analyzed 14 participants 16 participants
43.1  (4.13) 43.4  (3.88)
Albumin; Week 24; n=11, 15 Number Analyzed 11 participants 15 participants
0.0  (3.66) 0.0  (3.87)
Albumin; Week 48; n=8, 13 Number Analyzed 8 participants 13 participants
1.3  (2.55) -0.8  (3.69)
24.Secondary Outcome
Title Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase
Hide Description Blood samples were collected for the analysis of clinical chemistry parameters such as ALP, ALT, AST and creatine kinase. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.
Time Frame Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Overall Number of Participants Analyzed 14 16
Mean (Standard Deviation)
Unit of Measure: International units per liter
ALP; Baseline; n=14, 16 Number Analyzed 14 participants 16 participants
91.9  (29.64) 114.9  (106.74)
ALP; Day 8; n=13, 15 Number Analyzed 13 participants 15 participants
1.9  (14.01) -1.2  (9.41)
ALP; Day 28; n=13, 16 Number Analyzed 13 participants 16 participants
-6.1  (10.71) -0.6  (11.37)
ALP; Week 8; n=11, 16 Number Analyzed 11 participants 16 participants
1.6  (15.6) 20.6  (63.97)
ALP; Week 12; n=12, 14 Number Analyzed 12 participants 14 participants
-0.8  (10.19) -0.3  (26.15)
ALP; Week 16; n=10, 16 Number Analyzed 10 participants 16 participants
3.1  (12.02) 8.2  (40.55)
ALP; Week 24; n=11, 15 Number Analyzed 11 participants 15 participants
1.7  (21.72) 3.3  (54.06)
ALP; Week 32; n=11, 14 Number Analyzed 11 participants 14 participants
6.9  (19.74) 20.5  (35.89)
ALP; Week 40; n=8, 12 Number Analyzed 8 participants 12 participants
2.3  (20.26) 7.8  (24.69)
ALP; Week 48; n=8, 13 Number Analyzed 8 participants 13 participants
28.0  (67.54) 13.8  (32.07)
ALP; Week 60; n=5, 12 Number Analyzed 5 participants 12 participants
6.0  (23.86) 12.8  (35.98)
ALP; Week 72; n=3, 4 Number Analyzed 3 participants 4 participants
-5.0  (19.29) 15.3  (10.21)
ALP; Week 84; n=0, 1 Number Analyzed 0 participants 1 participants
22.0 [1]   (NA)
ALT; Baseline; n=14, 16 Number Analyzed 14 participants 16 participants
24.9  (13.33) 37.4  (22.70)
ALT; Day 8; n=13, 15 Number Analyzed 13 participants 15 participants
0.0  (7.02) -3.8  (11.91)
ALT; Day 28; n=13, 16 Number Analyzed 13 participants 16 participants
0.4  (15.45) -5.3  (23.65)
ALT; Week 8; n=11, 16 Number Analyzed 11 participants 16 participants
1.2  (20.30) -9.2  (17.93)
ALT; Week 12; n=12, 14 Number Analyzed 12 participants 14 participants
-5.4  (4.94) -8.7  (23.36)
ALT; Week 16; n=10, 16 Number Analyzed 10 participants 16 participants
-5.2  (3.97) -10.1  (23.02)
ALT; Week 24; n=11, 15 Number Analyzed 11 participants 15 participants
3.1  (18.66) -14.5  (23.16)
ALT; Week 32; n=11, 14 Number Analyzed 11 participants 14 participants
0.9  (14.01) -10.6  (25.77)
ALT; Week 40; n=8, 12 Number Analyzed 8 participants 12 participants
-1.6  (8.75) -7.7  (25.86)
ALT; Week 48; n=8, 13 Number Analyzed 8 participants 13 participants
7.9  (20.02) -9.2  (23.50)
ALT; Week 60; n=5, 12 Number Analyzed 5 participants 12 participants
0.8  (7.19) -8.3  (24.28)
ALT; Week 72; n=3, 4 Number Analyzed 3 participants 4 participants
8.7  (17.67) -29.3  (33.06)
ALT; Week 84; n=0, 1 Number Analyzed 0 participants 1 participants
-3.0 [1]   (NA)
AST; Baseline; n=14, 16 Number Analyzed 14 participants 16 participants
28.9  (11.13) 34.9  (14.35)
AST; Day 8; n=13, 15 Number Analyzed 13 participants 15 participants
1.0  (11.50) -2.0  (9.17)
AST; Day 28; n=13, 16 Number Analyzed 13 participants 16 participants
-4.0  (10.13) -2.3  (17.08)
AST; Week 8; n=11, 16 Number Analyzed 11 participants 16 participants
-2.9  (7.57) -6.3  (9.64)
AST; Week 12; n=12, 14 Number Analyzed 12 participants 14 participants
-4.8  (4.07) -5.1  (11.78)
AST; Week 16; n=10, 16 Number Analyzed 10 participants 16 participants
-4.0  (2.94) -6.6  (12.27)
AST; Week 24; n=11, 15 Number Analyzed 11 participants 15 participants
1.7  (14.05) -10.1  (11.87)
AST; Week 32; n=11, 14 Number Analyzed 11 participants 14 participants
-1.7  (6.83) -7.4  (13.14)
AST; Week 40; n=8, 12 Number Analyzed 8 participants 12 participants
-4.9  (4.09) -4.1  (12.46)
AST; Week 48; n=8, 13 Number Analyzed 8 participants 13 participants
9.0  (27.77) -5.4  (10.47)
AST; Week 60; n=5, 12 Number Analyzed 5 participants 12 participants
-3.2  (1.64) -5.9  (9.24)
AST; Week 72; n=3, 4 Number Analyzed 3 participants 4 participants
1.3  (8.50) -13.8  (12.31)
AST; Week 84; n=0, 1 Number Analyzed 0 participants 1 participants
-8.0 [1]   (NA)
Creatine Kinase; Baseline; n=14, 16 Number Analyzed 14 participants 16 participants
162.4  (129.21) 130.3  (76.46)
Creatine Kinase; Day 8; n=13, 15 Number Analyzed 13 participants 15 participants
-2.1  (122.28) -1.5  (53.29)
Creatine Kinase; Day 28; n=13, 16 Number Analyzed 13 participants 16 participants
-35.6  (96.22) 37.0  (123.10)
Creatine Kinase; Week 8; n=11, 16 Number Analyzed 11 participants 16 participants
-16.4  (106.99) -7.3  (68.19)
Creatine Kinase; Week 12; n=12, 14 Number Analyzed 12 participants 14 participants
-18.8  (105.64) 0.4  (84.85)
Creatine Kinase; Week 16; n=10, 16 Number Analyzed 10 participants 16 participants
34.2  (81.44) 80.5  (305.19)
Creatine Kinase; Week 24; n=11, 15 Number Analyzed 11 participants 15 participants
-24.4  (82.07) -6.0  (67.29)
Creatine Kinase; Week 32; n=11, 14 Number Analyzed 11 participants 14 participants
2.3  (54.41) 23.4  (96.88)
Creatine Kinase; Week 40; n=8, 12 Number Analyzed 8 participants 12 participants
-50.0  (93.45) 66.3  (168.54)
Creatine Kinase; Week 48; n=8, 13 Number Analyzed 8 participants 13 participants
7.8  (71.57) 16.1  (68.96)
Creatine Kinase; Week 60; n=5, 12 Number Analyzed 5 participants 12 participants
-12.2  (23.30) 18.8  (86.19)
Creatine Kinase; Week 72; n=3, 4 Number Analyzed 3 participants 4 participants
35.0  (68.61) -29.0  (76.27)
Creatine Kinase; Week 84; n=0, 1 Number Analyzed 0 participants 1 participants
-134.0 [1]   (NA)
[1]
Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.
25.Secondary Outcome
Title Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels
Hide Description Blood samples were collected for the analysis of clinical chemistry parameters such as T. Bil and creatinine. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.
Time Frame Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Overall Number of Participants Analyzed 14 16
Mean (Standard Deviation)
Unit of Measure: Micromoles per liter
T. Bil.; Baseline; n=14, 16 Number Analyzed 14 participants 16 participants
10.0  (4.51) 7.5  (3.14)
T. Bil.; Day 8; n=13, 15 Number Analyzed 13 participants 15 participants
0.8  (6.81) -1.1  (2.12)
T. Bil.; Day 28; n=13, 16 Number Analyzed 13 participants 16 participants
-0.2  (6.19) 2.1  (9.78)
T. Bil.; Week 8; n=11, 16 Number Analyzed 11 participants 16 participants
0.0  (4.20) 3.1  (13.76)
T. Bil.; Week 12; n=12, 14 Number Analyzed 12 participants 14 participants
0.5  (4.76) -0.6  (2.14)
T. Bil.; Week 16; n=10, 16 Number Analyzed 10 participants 16 participants
0.6  (3.89) 1.9  (10.89)
T. Bil.; Week 24; n=11, 15 Number Analyzed 11 participants 15 participants
0.2  (2.89) 2.1  (8.19)
T. Bil.; Week 32; n=11, 14 Number Analyzed 11 participants 14 participants
-0.4  (3.20) 2.3  (10.16)
T. Bil.; Week 40; n=8, 12 Number Analyzed 8 participants 12 participants
0.0  (3.70) 3.3  (12.43)
T. Bil.; Week 48; n=8, 13 Number Analyzed 8 participants 13 participants
-0.8  (4.13) 3.2  (12.18)
T. Bil.; Week 60; n=5, 12 Number Analyzed 5 participants 12 participants
-2.4  (2.61) 2.3  (11.63)
T. Bil.; Week 72; n=3, 4 Number Analyzed 3 participants 4 participants
-1.3  (4.16) 9.5  (16.36)
T. Bil.; Week 84; n=0, 1 Number Analyzed 0 participants 1 participants
2.0 [1]   (NA)
Creatinine; Baseline; n=14, 16 Number Analyzed 14 participants 16 participants
86.94  (18.971) 88.96  (24.013)
Creatinine; Day 8; n=13, 15 Number Analyzed 13 participants 15 participants
10.96  (24.505) 0.11  (14.873)
Creatinine; Day 28; n=13, 16 Number Analyzed 13 participants 16 participants
12.72  (19.697) 13.58  (21.030)
Creatinine; Week 8; n=11, 16 Number Analyzed 11 participants 16 participants
12.15  (8.570) 15.79  (19.574)
Creatinine; Week 12; n=12, 14 Number Analyzed 12 participants 14 participants
6.86  (9.153) 9.85  (13.274)
Creatinine; Week 16; n=10, 16 Number Analyzed 10 participants 16 participants
8.22  (13.464) 7.68  (13.031)
Creatinine; Week 24; n=11, 15 Number Analyzed 11 participants 15 participants
1.63  (11.098) 13.31  (17.347)
Creatinine; Week 32; n=11, 14 Number Analyzed 11 participants 14 participants
0.98  (7.441) 15.96  (11.902)
Creatinine; Week 40; n=8, 12 Number Analyzed 8 participants 12 participants
3.58  (10.788) 12.94  (13.870)
Creatinine; Week 48; n=8, 13 Number Analyzed 8 participants 13 participants
4.21  (19.450) 12.85  (9.128)
Creatinine; Week 60; n=5, 12 Number Analyzed 5 participants 12 participants
4.96  (5.560) 11.72  (15.820)
Creatinine; Week 72; n=3, 4 Number Analyzed 3 participants 4 participants
0.93  (8.529) 13.25  (16.957)
Creatinine; Week 84; n=0, 1 Number Analyzed 0 participants 1 participants
1.80 [1]   (NA)
[1]
Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.
26.Secondary Outcome
Title Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen
Hide Description Blood samples were collected for the analysis of clinical chemistry parameters such as cholesterol, chloride, CO2/HCO3, glucose, high density lipoprotein (HDL) cholesterol, potassium, LDL cholesterol, sodium, phosphorus inorganic, triglycerides and urea/blood urea nitrogen (BUN). Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.
Time Frame Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Lipid and glucose parameters were only summarized on fasting data. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Overall Number of Participants Analyzed 14 16
Mean (Standard Deviation)
Unit of Measure: Millimoles per liter
Cholesterol; Baseline; n=8, 10 Number Analyzed 8 participants 10 participants
3.819  (0.9219) 4.725  (1.7430)
Cholesterol; Week 12; n=6, 8 Number Analyzed 6 participants 8 participants
0.433  (0.4622) 0.538  (0.9598)
Cholesterol; Week 24; n=6, 10 Number Analyzed 6 participants 10 participants
0.308  (0.3137) 0.585  (1.0296)
Cholesterol; Week 48; n=3, 7 Number Analyzed 3 participants 7 participants
0.567  (0.2021) 0.421  (1.2770)
Cholesterol; Week 60; n=2, 5 Number Analyzed 2 participants 5 participants
0.375  (0.9546) -0.020  (1.3326)
Cholesterol; Week 72; n=0, 1 Number Analyzed 0 participants 1 participants
1.350 [1]   (NA)
Chloride; Baseline; n=14, 16 Number Analyzed 14 participants 16 participants
104.1  (1.59) 105.4  (3.32)
Chloride; Day 8; n=13, 15 Number Analyzed 13 participants 15 participants
0.5  (1.61) 0.4  (2.03)
Chloride; Day 28; n=13, 16 Number Analyzed 13 participants 16 participants
0.4  (2.26) -0.5  (2.58)
Chloride; Week 8; n=11, 16 Number Analyzed 11 participants 16 participants
0.5  (1.97) -1.8  (3.08)
Chloride; Week 12; n=12, 14 Number Analyzed 12 participants 14 participants
-0.8  (1.71) 0.1  (2.73)
Chloride; Week 16; n=10, 16 Number Analyzed 10 participants 16 participants
1.4  (1.90) -1.0  (2.73)
Chloride; Week 24; n=11, 15 Number Analyzed 11 participants 15 participants
0.9  (1.45) -1.2  (3.14)
Chloride; Week 32; n=11, 14 Number Analyzed 11 participants 14 participants
1.1  (2.21) 0.0  (2.57)
Chloride; Week 40; n=8, 12 Number Analyzed 8 participants 12 participants
0.5  (2.51) 1.3  (2.80)
Chloride; Week 48; n=8, 13 Number Analyzed 8 participants 13 participants
1.5  (3.74) -0.1  (3.38)
Chloride; Week 60; n=5, 12 Number Analyzed 5 participants 12 participants
2.0  (2.12) 1.1  (2.81)
Chloride; Week 72; n=3, 4 Number Analyzed 3 participants 4 participants
2.0  (2.65) 1.0  (2.94)
Chloride; Week 84; n=0, 1 Number Analyzed 0 participants 1 participants
-2.0 [1]   (NA)
CO2/HCO3; Baseline; n=14, 16 Number Analyzed 14 participants 16 participants
22.5  (2.07) 20.8  (4.12)
CO2/HCO3; Day 8; n=13, 15 Number Analyzed 13 participants 15 participants
0.2  (1.30) 0.1  (2.25)
CO2/HCO3; Day 28; n=13, 16 Number Analyzed 13 participants 16 participants
0.4  (2.29) 1.1  (2.47)
CO2/HCO3; Week 8; n=11, 16 Number Analyzed 11 participants 16 participants
1.2  (1.66) 1.6  (3.40)
CO2/HCO3; Week 12; n=12, 14 Number Analyzed 12 participants 14 participants
1.7  (1.92) 1.9  (2.73)
CO2/HCO3; Week 16; n=10, 16 Number Analyzed 10 participants 16 participants
-0.2  (2.39) 1.8  (3.42)
CO2/HCO3; Week 24; n=11, 15 Number Analyzed 11 participants 15 participants
0.9  (1.92) 1.5  (2.92)
CO2/HCO3; Week 32; n=11, 14 Number Analyzed 11 participants 14 participants
1.5  (2.21) 0.8  (2.69)
CO2/HCO3; Week 40; n=8, 12 Number Analyzed 8 participants 12 participants
0.9  (2.30) -0.2  (2.25)
CO2/HCO3; Week 48; n=8, 13 Number Analyzed 8 participants 13 participants
-0.4  (2.13) 1.7  (3.01)
CO2/HCO3; Week 60; n=5, 12 Number Analyzed 5 participants 12 participants
0.8  (1.30) 0.3  (2.42)
CO2/HCO3; Week 72; n=3, 4 Number Analyzed 3 participants 4 participants
2.0  (3.61) -0.3  (1.89)
CO2/HCO3; Week 84; n=0, 1 Number Analyzed 0 participants 1 participants
4.0 [1]   (NA)
Glucose; Baseline; n=12, 16 Number Analyzed 12 participants 16 participants
4.84  (0.535) 5.56  (1.994)
Glucose; Week 12; n=11, 14 Number Analyzed 11 participants 14 participants
-0.01  (0.677) 0.04  (0.679)
Glucose; Week 24; n=10, 15 Number Analyzed 10 participants 15 participants
0.17  (0.957) -0.08  (1.024)
Glucose; Week 48; n=7, 13 Number Analyzed 7 participants 13 participants
0.13  (0.439) 0.40  (1.143)
Glucose; Week 60; n=3, 12 Number Analyzed 3 participants 12 participants
0.20  (0.300) -0.18  (0.723)
Glucose; Week 72; n=2, 4 Number Analyzed 2 participants 4 participants
0.45  (0.071) 0.20  (0.744)
HDL Cholesterol; Baseline; n=8, 10 Number Analyzed 8 participants 10 participants
0.956  (0.2718) 1.090  (0.2846)
HDL Cholesterol; Week 12; n=6, 8 Number Analyzed 6 participants 8 participants
0.117  (0.0683) 0.156  (0.2485)
HDL Cholesterol; Week 24; n=6, 10 Number Analyzed 6 participants 10 participants
0.025  (0.1864) 0.130  (0.2573)
HDL Cholesterol; Week 48; n=3, 7 Number Analyzed 3 participants 7 participants
0.117  (0.1155) 0.136  (0.3363)
HDL Cholesterol; Week 60; n=2, 5 Number Analyzed 2 participants 5 participants
-0.025  (0.0354) 0.010  (0.3896)
HDL Cholesterol; Week 72; n=0, 1 Number Analyzed 0 participants 1 participants
0.350 [1]   (NA)
Potassium; Baseline; n=14, 16 Number Analyzed 14 participants 16 participants
4.16  (0.420) 4.13  (0.377)
Potassium; Day 8; n=13, 15 Number Analyzed 13 participants 15 participants
-0.09  (0.198) -0.01  (0.301)
Potassium; Day 28; n=13, 16 Number Analyzed 13 participants 16 participants
0.19  (0.439) 0.14  (0.518)
Potassium; Week 8; n=11, 16 Number Analyzed 11 participants 16 participants
0.12  (0.379) 0.19  (0.421)
Potassium; Week 12; n=12, 14 Number Analyzed 12 participants 14 participants
0.03  (0.253) 0.06  (0.373)
Potassium; Week 16; n=10, 16 Number Analyzed 10 participants 16 participants
-0.06  (0.360) -0.08  (0.556)
Potassium; Week 24; n=11, 15 Number Analyzed 11 participants 15 participants
0.17  (0.374) 0.27  (0.641)
Potassium; Week 32; n=11, 14 Number Analyzed 11 participants 14 participants
-0.04  (0.329) 0.27  (0.327)
Potassium; Week 40; n=8, 12 Number Analyzed 8 participants 12 participants
-0.01  (0.189) 0.12  (0.259)
Potassium; Week 48; n=8, 13 Number Analyzed 8 participants 13 participants
0.15  (0.532) 0.28  (0.508)
Potassium; Week 60; n=5, 12 Number Analyzed 5 participants 12 participants
0.06  (0.288) 0.03  (0.614)
Potassium; Week 72; n=3, 4 Number Analyzed 3 participants 4 participants
0.37  (0.208) 0.02  (0.512)
Potassium; Week 84; n=0, 1 Number Analyzed 0 participants 1 participants
0.20 [1]   (NA)
LDL Cholesterol; Baseline; n=8, 9 Number Analyzed 8 participants 9 participants
2.218  (0.9134) 2.591  (1.3696)
LDL Cholesterol; Week 12; n=6, 8 Number Analyzed 6 participants 8 participants
0.293  (0.4197) 0.500  (0.5145)
LDL Cholesterol; Week 24; n=6, 9 Number Analyzed 6 participants 9 participants
0.032  (0.5854) 0.596  (0.7389)
LDL Cholesterol; Week 48; n=3, 6 Number Analyzed 3 participants 6 participants
0.330  (0.0458) 0.322  (0.7725)
LDL Cholesterol; Week 60; n=2, 4 Number Analyzed 2 participants 4 participants
0.125  (0.5303) -0.008  (1.0682)
LDL Cholesterol; Week 72; n=0, 1 Number Analyzed 0 participants 1 participants
1.110 [1]   (NA)
Sodium; Baseline; n=14, 16 Number Analyzed 14 participants 16 participants
138.8  (2.26) 138.5  (2.22)
Sodium; Day 8; n=13, 15 Number Analyzed 13 participants 15 participants
0.2  (1.64) -0.1  (2.02)
Sodium; Day 28; n=13, 16 Number Analyzed 13 participants 16 participants
-0.2  (3.11) -0.4  (2.60)
Sodium; Week 8; n=11, 16 Number Analyzed 11 participants 16 participants
0.2  (2.14) -0.4  (2.03)
Sodium; Week 12; n=12, 14 Number Analyzed 12 participants 14 participants
-0.5  (1.88) 0.4  (2.53)
Sodium; Week 16; n=10, 16 Number Analyzed 10 participants 16 participants
1.3  (2.06) 0.2  (1.94)
Sodium; Week 24; n=11, 15 Number Analyzed 11 participants 15 participants
0.5  (1.51) -0.1  (2.33)
Sodium; Week 32; n=11, 14 Number Analyzed 11 participants 14 participants
0.8  (1.60) 0.1  (1.41)
Sodium; Week 40; n=8, 12 Number Analyzed 8 participants 12 participants
1.0  (2.14) 0.5  (1.57)
Sodium; Week 48; n=8, 13 Number Analyzed 8 participants 13 participants
0.9  (3.56) 0.9  (2.40)
Sodium; Week 60; n=5, 12 Number Analyzed 5 participants 12 participants
2.4  (1.95) 0.7  (2.46)
Sodium; Week 72; n=3, 4 Number Analyzed 3 participants 4 participants
1.3  (2.52) 0.3  (1.50)
Sodium; Week 84; n=0, 1 Number Analyzed 0 participants 1 participants
0.0 [1]   (NA)
Phosphorus, inorganic; Baseline; n=14, 16 Number Analyzed 14 participants 16 participants
1.018  (0.1552) 1.128  (0.1390)
Phosphorus, inorganic; Day 8; n=13, 15 Number Analyzed 13 participants 15 participants
0.012  (0.1261) -0.123  (0.1635)
Phosphorus, inorganic; Day 28; n=13, 16 Number Analyzed 13 participants 16 participants
0.065  (0.2357) -0.075  (0.1713)
Phosphorus, inorganic; Week 8; n=11, 16 Number Analyzed 11 participants 16 participants
0.018  (0.1722) -0.075  (0.2244)
Phosphorus, inorganic; Week 12; n=12, 14 Number Analyzed 12 participants 14 participants
0.033  (0.1542) -0.054  (0.1322)
Phosphorus, inorganic; Week 16; n=10, 16 Number Analyzed 10 participants 16 participants
0.080  (0.2263) -0.053  (0.2617)
Phosphorus, inorganic; Week 24; n=11, 15 Number Analyzed 11 participants 15 participants
-0.050  (0.1204) -0.023  (0.1954)
Phosphorus, inorganic; Week 32; n=11, 14 Number Analyzed 11 participants 14 participants
-0.036  (0.1343) -0.050  (0.1787)
Phosphorus, inorganic; Week 40; n=8, 12 Number Analyzed 8 participants 12 participants
0.000  (0.1035) -0.046  (0.2340)
Phosphorus, inorganic; Week 48; n=8, 13 Number Analyzed 8 participants 13 participants
0.025  (0.1282) -0.031  (0.1331)
Phosphorus, inorganic; Week 60; n=5, 12 Number Analyzed 5 participants 12 participants
0.020  (0.1304) -0.042  (0.1311)
Phosphorus, inorganic; Week 72; n=3, 4 Number Analyzed 3 participants 4 participants
0.017  (0.1258) 0.013  (0.1031)
Phosphorus, inorganic; Week 84; n=0, 1 Number Analyzed 0 participants 1 participants
0.100 [1]   (NA)
Triglycerides; Baseline; n=8, 10 Number Analyzed 8 participants 10 participants
1.410  (0.5005) 2.336  (1.1103)
Triglycerides; Week 12; n=6, 8 Number Analyzed 6 participants 8 participants
0.047  (0.6380) -0.260  (1.1159)
Triglycerides; Week 24; n=6, 10 Number Analyzed 6 participants 10 participants
0.547  (0.9273) -0.458  (1.2066)
Triglycerides; Week 48; n=3, 7 Number Analyzed 3 participants 7 participants
0.260  (0.3894) -0.486  (1.3993)
Triglycerides; Week 60; n=2, 5 Number Analyzed 2 participants 5 participants
0.590  (0.8344) -0.580  (1.0562)
Triglycerides; Week 72; n=0, 1 Number Analyzed 0 participants 1 participants
-0.240 [1]   (NA)
Urea/BUN; Baseline; n=14, 16 Number Analyzed 14 participants 16 participants
5.64  (1.167) 5.72  (2.324)
Urea/BUN; Day 8; n=13, 15 Number Analyzed 13 participants 15 participants
0.04  (1.233) -0.43  (1.252)
Urea/BUN; Day 28; n=13, 16 Number Analyzed 13 participants 16 participants
-0.23  (1.678) -0.13  (1.875)
Urea/BUN; Week 8; n=11, 16 Number Analyzed 11 participants 16 participants
-0.09  (1.200) -0.59  (1.985)
Urea/BUN; Week 12; n=12, 14 Number Analyzed 12 participants 14 participants
0.25  (1.270) -0.50  (1.676)
Urea/BUN; Week 16; n=10, 16 Number Analyzed 10 participants 16 participants
-0.05  (1.787) -1.00  (1.304)
Urea/BUN; Week 24; n=11, 15 Number Analyzed 11 participants 15 participants
-0.09  (1.200) -0.27  (1.841)
Urea/BUN; Week 32; n=11, 14 Number Analyzed 11 participants 14 participants
-0.55  (1.150) 0.57  (1.708)
Urea/BUN; Week 40; n=8, 12 Number Analyzed 8 participants 12 participants
-0.19  (1.387) 0.29  (1.339)
Urea/BUN; Week 48; n=8, 13 Number Analyzed 8 participants 13 participants
0.38  (1.157) 0.88  (1.927)
Urea/BUN; Week 60; n=5, 12 Number Analyzed 5 participants 12 participants
0.30  (0.908) 0.54  (1.888)
Urea/BUN; Week 72; n=3, 4 Number Analyzed 3 participants 4 participants
0.50  (0.500) 0.50  (0.408)
Urea/BUN; Week 84; n=0, 1 Number Analyzed 0 participants 1 participants
0.00 [1]   (NA)
[1]
Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.
27.Secondary Outcome
Title Change From Baseline in Creatinine Clearance
Hide Description Creatinine clearance was calculated using Cockcroft-Gault formula. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.
Time Frame Baseline, Day 8, Day 28, Week 8, Week 16, Week 24, Week 32 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Overall Number of Participants Analyzed 14 16
Mean (Standard Deviation)
Unit of Measure: Milliliters per minute
Baseline; n=14, 16 Number Analyzed 14 participants 16 participants
106.8  (31.79) 104.8  (36.96)
Day 8; n=1, 0 Number Analyzed 1 participants 0 participants
-13.0 [1]   (NA)
Day 28; n=13, 16 Number Analyzed 13 participants 16 participants
-10.5  (13.06) -10.4  (13.06)
Week 8; n=0, 1 Number Analyzed 0 participants 1 participants
-12.0 [1]   (NA)
Week 16; n=10, 15 Number Analyzed 10 participants 15 participants
-7.3  (12.00) -12.5  (16.41)
Week 24; n=11, 15 Number Analyzed 11 participants 15 participants
-2.3  (13.94) -13.9  (17.38)
Week 32; n=9, 14 Number Analyzed 9 participants 14 participants
-1.4  (8.82) -16.0  (16.31)
Week 48; n=6, 12 Number Analyzed 6 participants 12 participants
-6.8  (17.61) -16.5  (14.34)
[1]
Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.
28.Secondary Outcome
Title Change From Baseline in Lipase Levels
Hide Description Blood samples were collected for the analysis of clinical chemistry parameters such as lipase level. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.
Time Frame Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Overall Number of Participants Analyzed 14 16
Mean (Standard Deviation)
Unit of Measure: Units per liter
Lipase; Baseline; n=14, 16 Number Analyzed 14 participants 16 participants
29.1  (12.37) 34.0  (18.54)
Lipase; Day 8; n=14, 15 Number Analyzed 14 participants 15 participants
3.4  (9.19) 12.5  (32.97)
Lipase; Day 28; n=13, 16 Number Analyzed 13 participants 16 participants
3.3  (9.18) 17.7  (63.64)
Lipase; Week 8; n=11, 16 Number Analyzed 11 participants 16 participants
2.6  (8.65) 13.6  (42.89)
Lipase; Week 12; n=11, 14 Number Analyzed 11 participants 14 participants
-2.4  (8.91) 3.0  (19.24)
Lipase; Week 16; n=10, 16 Number Analyzed 10 participants 16 participants
7.6  (13.94) -0.8  (12.90)
Lipase; Week 24; n=11, 15 Number Analyzed 11 participants 15 participants
-2.7  (9.91) 10.5  (29.18)
Lipase; Week 32; n=11, 14 Number Analyzed 11 participants 14 participants
0.8  (9.82) 20.6  (49.70)
Lipase; Week 40; n=8, 12 Number Analyzed 8 participants 12 participants
0.6  (8.53) 5.6  (19.78)
Lipase; Week 48; n=8, 13 Number Analyzed 8 participants 13 participants
3.8  (6.18) 3.4  (16.05)
Lipase; Week 60; n=5, 12 Number Analyzed 5 participants 12 participants
5.0  (8.40) 5.9  (22.01)
Lipase; Week 72; n=3, 4 Number Analyzed 3 participants 4 participants
16.0  (14.11) 41.0  (94.20)
Lipase; Week 84; n=0, 1 Number Analyzed 0 participants 1 participants
-9.0 [1]   (NA)
[1]
Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.
29.Secondary Outcome
Title Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count
Hide Description Blood samples were collected for the analysis of hematology parameters such as basophils, eosinophils. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.
Time Frame Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Overall Number of Participants Analyzed 14 16
Mean (Standard Deviation)
Unit of Measure: Giga cells per liter
Basophils; Baseline; n=14, 16 Number Analyzed 14 participants 16 participants
0.016  (0.0122) 0.015  (0.0126)
Basophils; Day 8; n=14, 15 Number Analyzed 14 participants 15 participants
0.006  (0.0134) 0.002  (0.0094)
Basophils; Day 28; n=13, 16 Number Analyzed 13 participants 16 participants
0.005  (0.0176) 0.004  (0.0222)
Basophils; Week 8; n=11, 16 Number Analyzed 11 participants 16 participants
-0.001  (0.0122) 0.004  (0.0120)
Basophils; Week 12; n=12, 14 Number Analyzed 12 participants 14 participants
-0.001  (0.0144) 0.000  (0.0124)
Basophils; Week 16; n=12, 16 Number Analyzed 12 participants 16 participants
-0.002  (0.0147) 0.005  (0.0137)
Basophils; Week 24; n=11, 15 Number Analyzed 11 participants 15 participants
0.001  (0.0158) 0.007  (0.0188)
Basophils; Week 32; n=11, 13 Number Analyzed 11 participants 13 participants
0.002  (0.0108) 0.005  (0.0185)
Basophils; Week 40; n=8, 12 Number Analyzed 8 participants 12 participants
-0.000  (0.0207) 0.003  (0.0144)
Basophils; Week 48; n=8, 13 Number Analyzed 8 participants 13 participants
0.006  (0.0130) 0.008  (0.0174)
Basophils; Week 60; n=5, 12 Number Analyzed 5 participants 12 participants
-0.002  (0.0164) 0.004  (0.0173)
Basophils; Week 72; n=3, 4 Number Analyzed 3 participants 4 participants
-0.003  (0.0153) 0.008  (0.0275)
Basophils; Week 84; n=0, 1 Number Analyzed 0 participants 1 participants
0.010 [1]   (NA)
Eosinophils; Baseline; n=14, 16 Number Analyzed 14 participants 16 participants
0.087  (0.0935) 0.158  (0.1681)
Eosinophils; Day 8; n=14, 15 Number Analyzed 14 participants 15 participants
0.016  (0.0388) 0.005  (0.1076)
Eosinophils; Day 28; n=13, 16 Number Analyzed 13 participants 16 participants
0.023  (0.0253) 0.033  (0.1939)
Eosinophils; Week 8; n=11, 16 Number Analyzed 11 participants 16 participants
0.041  (0.0561) 0.090  (0.1464)
Eosinophils; Week 12; n=12, 14 Number Analyzed 12 participants 14 participants
0.023  (0.0492) 0.240  (0.4390)
Eosinophils; Week 16; n=12, 16 Number Analyzed 12 participants 16 participants
0.024  (0.0887) 0.141  (0.3009)
Eosinophils; Week 24; n=11, 15 Number Analyzed 11 participants 15 participants
-0.003  (0.0987) 0.159  (0.3737)
Eosinophils; Week 32; n=11, 13 Number Analyzed 11 participants 13 participants
0.016  (0.1108) 0.075  (0.1921)
Eosinophils; Week 40; n=8, 12 Number Analyzed 8 participants 12 participants
-0.015  (0.1285) 0.011  (0.1054)
Eosinophils; Week 48; n=8, 13 Number Analyzed 8 participants 13 participants
-0.028  (0.1241) 0.122  (0.2186)
Eosinophils; Week 60; n=5, 12 Number Analyzed 5 participants 12 participants
-0.038  (0.1392) 0.098  (0.2143)
Eosinophils; Week 72; n=3, 4 Number Analyzed 3 participants 4 participants
-0.043  (0.1185) 0.053  (0.0660)
Eosinophils; Week 84; n=0, 1 Number Analyzed 0 participants 1 participants
0.240 [1]   (NA)
Lymphocytes; Baseline; n=14, 16 Number Analyzed 14 participants 16 participants
1.656  (0.9039) 1.418  (0.7921)
Lymphocytes; Day 8; n=14, 15 Number Analyzed 14 participants 15 participants
0.165  (0.4910) 0.040  (0.3262)
Lymphocytes; Day 28; n=13, 16 Number Analyzed 13 participants 16 participants
0.132  (0.4841) 0.297  (0.3042)
Lymphocytes; Week 8; n=11, 16 Number Analyzed 11 participants 16 participants
0.490  (0.5591) 0.536  (0.6238)
Lymphocytes; Week 12; n=12, 14 Number Analyzed 12 participants 14 participants
0.417  (0.9401) 0.525  (0.4922)
Lymphocytes; Week 16; n=12, 16 Number Analyzed 12 participants 16 participants
0.554  (0.6402) 0.594  (0.7014)
Lymphocytes; Week 24; n=11, 15 Number Analyzed 11 participants 15 participants
0.271  (0.7466) 0.647  (0.8692)
Lymphocytes; Week 32; n=11, 13 Number Analyzed 11 participants 13 participants
0.173  (0.7166) 0.818  (0.6910)
Lymphocytes; Week 40; n=8, 12 Number Analyzed 8 participants 12 participants
0.169  (0.6600) 0.519  (0.6709)
Lymphocytes; Week 48; n=8, 13 Number Analyzed 8 participants 13 participants
0.474  (0.4207) 0.563  (0.5703)
Lymphocytes; Week 60; n=5, 12 Number Analyzed 5 participants 12 participants
0.526  (0.3578) 0.663  (0.6135)
Lymphocytes; Week 72; n=3, 4 Number Analyzed 3 participants 4 participants
0.673  (0.5327) 0.623  (0.4280)
Lymphocytes; Week 84; n=0, 1 Number Analyzed 0 participants 1 participants
0.640 [1]   (NA)
Monocytes; Baseline; n=14, 16 Number Analyzed 14 participants 16 participants
0.367  (0.2075) 0.306  (0.1117)
Monocytes; Day 8; n=14, 15 Number Analyzed 14 participants 15 participants
0.003  (0.2379) 0.027  (0.1460)
Monocytes; Day 28; n=13, 16 Number Analyzed 13 participants 16 participants
-0.042  (0.1999) 0.031  (0.1196)
Monocytes; Week 8; n=11, 16 Number Analyzed 11 participants 16 participants
-0.022  (0.1256) 0.037  (0.1111)
Monocytes; Week 12; n=12, 14 Number Analyzed 12 participants 14 participants
-0.053  (0.1215) 0.065  (0.1075)
Monocytes; Week 16; n=12, 16 Number Analyzed 12 participants 16 participants
-0.027  (0.1262) 0.089  (0.1430)
Monocytes; Week 24; n=11, 15 Number Analyzed 11 participants 15 participants
-0.067  (0.1152) 0.017  (0.1716)
Monocytes; Week 32; n=11, 13 Number Analyzed 11 participants 14 participants
-0.059  (0.1208) 0.017  (0.1616)
Monocytes; Week 40; n=8, 12 Number Analyzed 8 participants 12 participants
-0.030  (0.0685) 0.011  (0.0983)
Monocytes; Week 48; n=8, 13 Number Analyzed 8 participants 13 participants
-0.050  (0.1598) 0.018  (0.0985)
Monocytes; Week 60; n=5, 12 Number Analyzed 5 participants 12 participants
-0.088  (0.1359) -0.003  (0.1305)
Monocytes; Week 72; n=3, 4 Number Analyzed 3 participants 4 participants
0.003  (0.0987) 0.055  (0.1196)
Monocytes; Week 84; n=0, 1 Number Analyzed 0 participants 1 participants
-0.230 [1]   (NA)
Total neutrophils; Baseline; n=14, 16 Number Analyzed 14 participants 16 participants
2.327  (1.2068) 1.869  (1.0565)
Total neutrophils; Day 8; n=14, 15 Number Analyzed 14 participants 15 participants
0.090  (0.9029) 0.072  (0.6338)
Total neutrophils; Day 28; n=13, 16 Number Analyzed 13 participants 16 participants
0.196  (0.7017) 0.659  (0.9376)
Total neutrophils; Week 8; n=11, 16 Number Analyzed 11 participants 16 participants
0.480  (0.7919) 0.344  (0.7325)
Total neutrophils; Week 12; n=12, 14 Number Analyzed 12 participants 14 participants
0.022  (0.5946) 0.357  (0.5410)
Total neutrophils; Week 16; n=12, 16 Number Analyzed 12 participants 16 participants
0.780  (1.7187) 1.030  (0.7759)
Total neutrophils; Week 24; n=11, 15 Number Analyzed 11 participants 15 participants
-0.128  (0.7851) 0.746  (1.3053)
Total neutrophils; Week 32; n=11, 13 Number Analyzed 11 participants 13 participants
0.213  (0.9525) 0.875  (1.0945)
Total neutrophils; Week 40; n=8, 12 Number Analyzed 8 participants 12 participants
0.224  (1.0274) 0.390  (0.4501)
Total neutrophils; Week 48; n=8, 13 Number Analyzed 8 participants 13 participants
0.144  (0.5807) 0.986  (1.0983)
Total neutrophils; Week 60; n=5, 12 Number Analyzed 5 participants 12 participants
0.162  (0.7959) 1.507  (1.7191)
Total neutrophils; Week 72; n=3, 4 Number Analyzed 3 participants 4 participants
0.783  (1.6101) 2.363  (2.0072)
Total neutrophils; Week 84; n=0, 1 Number Analyzed 0 participants 1 participants
2.060 [1]   (NA)
Platelet; Baseline; n=14, 16 Number Analyzed 14 participants 16 participants
173.0  (65.30) 176.9  (56.97)
Platelet; Day 8; n=14, 15 Number Analyzed 14 participants 15 participants
21.6  (29.23) 16.5  (29.08)
Platelet; Day 28; n=13, 16 Number Analyzed 13 participants 16 participants
33.9  (29.87) 30.8  (43.76)
Platelet; Week 8; n=11, 16 Number Analyzed 11 participants 16 participants
57.8  (70.86) 29.1  (57.51)
Platelet; Week 12; n=12, 14 Number Analyzed 12 participants 14 participants
36.5  (33.68) 39.2  (56.51)
Platelet; Week 16; n=12, 16 Number Analyzed 12 participants 16 participants
35.7  (39.58) 52.6  (56.43)
Platelet; Week 24; n=11, 15 Number Analyzed 11 participants 15 participants
33.5  (31.41) 58.7  (64.10)
Platelet; Week 32; n=11, 13 Number Analyzed 11 participants 13 participants
12.1  (33.87) 55.6  (74.60)
Platelet; Week 40; n=8, 12 Number Analyzed 8 participants 12 participants
25.6  (38.38) 44.9  (48.17)
Platelet; Week 48; n=8, 13 Number Analyzed 8 participants 13 participants
24.6  (36.49) 53.5  (63.73)
Platelet; Week 60; n=5, 12 Number Analyzed 5 participants 12 participants
43.0  (18.36) 51.5  (58.12)
Platelet; Week 72; n=3, 4 Number Analyzed 3 participants 4 participants
34.3  (40.15) 64.0  (94.89)
Platelet; Week 84; n=0, 1 Number Analyzed 0 participants 1 participants
88.0 [1]   (NA)
WBC; Baseline; n=14, 16 Number Analyzed 14 participants 16 participants
4.44  (1.752) 3.78  (1.522)
WBC; Day 8; n=14, 15 Number Analyzed 14 participants 15 participants
0.29  (1.082) 0.15  (0.890)
WBC; Day 28; n=13, 16 Number Analyzed 13 participants 16 participants
0.33  (0.946) 1.03  (1.105)
WBC; Week 8; n=11, 16 Number Analyzed 11 participants 16 participants
1.00  (1.015) 1.02  (1.008)
WBC; Week 12; n=12, 14 Number Analyzed 12 participants 14 participants
0.42  (1.192) 1.19  (1.005)
WBC; Week 16; n=12, 16 Number Analyzed 12 participants 16 participants
1.36  (2.050) 1.86  (1.398)
WBC; Week 24; n=11, 15 Number Analyzed 11 participants 15 participants
0.09  (1.276) 1.59  (2.075)
WBC; Week 32; n=11, 13 Number Analyzed 11 participants 13 participants
0.35  (1.264) 1.78  (1.600)
WBC; Week 40; n=8, 12 Number Analyzed 8 participants 12 participants
0.36  (1.162) 0.93  (0.965)
WBC; Week 48; n=8, 13 Number Analyzed 8 participants 13 participants
0.56  (0.655) 1.70  (1.480)
WBC; Week 60; n=5, 12 Number Analyzed 5 participants 12 participants
0.58  (0.973) 2.25  (1.579)
WBC; Week 72; n=3, 4 Number Analyzed 3 participants 4 participants
1.43  (1.210) 3.10  (2.349)
WBC; Week 84; n=0, 1 Number Analyzed 0 participants 1 participants
2.70 [1]   (NA)
[1]
Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.
30.Secondary Outcome
Title Change From Baseline in Hemoglobin Level
Hide Description Blood samples were collected for the analysis of hematology parameters such as hemoglobin. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.
Time Frame Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Overall Number of Participants Analyzed 14 16
Mean (Standard Deviation)
Unit of Measure: Grams per liter
Baseline; n=14, 16 Number Analyzed 14 participants 16 participants
132.9  (16.16) 129.9  (21.08)
Day 8; n=14, 15 Number Analyzed 14 participants 15 participants
-1.0  (6.98) -1.3  (4.37)
Day 28; n=13, 16 Number Analyzed 13 participants 16 participants
-2.5  (8.76) -0.9  (9.62)
Week 8; n=11, 16 Number Analyzed 11 participants 16 participants
-4.5  (13.71) 2.6  (12.48)
Week 12; n=12, 14 Number Analyzed 12 participants 14 participants
-1.0  (12.59) 2.1  (11.02)
Week 16; n=12 16 Number Analyzed 12 participants 16 participants
0.0  (15.47) 1.9  (10.14)
Week 24; n=11, 15 Number Analyzed 11 participants 15 participants
-0.6  (10.60) 1.5  (8.82)
Week 32; n=11, 13 Number Analyzed 11 participants 13 participants
-2.4  (10.66) 1.5  (9.49)
Week 40; n=8, 12 Number Analyzed 8 participants 12 participants
-0.9  (12.14) 0.7  (11.32)
Week 48; n=8, 13 Number Analyzed 8 participants 13 participants
0.0  (9.80) 0.5  (13.48)
Week 60; n=5, 12 Number Analyzed 5 participants 12 participants
-1.8  (13.99) 5.0  (13.22)
Week 72; n=3, 4 Number Analyzed 3 participants 4 participants
-4.3  (7.37) 7.0  (8.72)
Week 84; n=0, 1 Number Analyzed 0 participants 1 participants
-6.0 [1]   (NA)
[1]
Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.
31.Secondary Outcome
Title Change From Baseline in Hematocrit Level
Hide Description Blood samples were collected for the analysis of hematology parameters such as hematocrit level. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.
Time Frame Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Overall Number of Participants Analyzed 14 16
Mean (Standard Deviation)
Unit of Measure: Proportion of red blood cells in blood
Baseline; n=14, 16 Number Analyzed 14 participants 16 participants
0.4024  (0.05259) 0.3974  (0.06496)
Day 8; n=14, 15 Number Analyzed 14 participants 15 participants
-0.0015  (0.02666) -0.0049  (0.01515)
Day 28; n=13, 16 Number Analyzed 13 participants 16 participants
-0.0066  (0.03105) -0.0043  (0.03313)
Week 8; n=11, 16 Number Analyzed 11 participants 16 participants
-0.0105  (0.04383) 0.0092  (0.04092)
Week 12; n=12, 14 Number Analyzed 12 participants 14 participants
-0.0027  (0.03702) 0.0054  (0.03419)
Week 16; n=12, 16 Number Analyzed 12 participants 16 participants
-0.0033  (0.04275) 0.0021  (0.03054)
Week 24; n=11, 15 Number Analyzed 11 participants 15 participants
-0.0025  (0.03707) 0.0062  (0.02787)
Week 32; n=11, 13 Number Analyzed 11 participants 13 participants
-0.0081  (0.03310) 0.0062  (0.03144)
Week 40; n=8, 12 Number Analyzed 8 participants 12 participants
-0.0005  (0.03257) 0.0063  (0.03601)
Week 48; n=8, 13 Number Analyzed 8 participants 13 participants
0.0065  (0.02919) 0.0078  (0.04331)
Week 60; n=5, 12 Number Analyzed 5 participants 12 participants
-0.0024  (0.04000) 0.0200  (0.04520)
Week 72; n=3, 4 Number Analyzed 3 participants 4 participants
-0.0170  (0.03119) 0.0248  (0.02943)
Week 84; n=0, 1 Number Analyzed 0 participants 1 participants
-0.0090 [1]   (NA)
[1]
Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.
32.Secondary Outcome
Title Change From Baseline in Mean Corpuscle Volume
Hide Description Blood samples were collected for the analysis of hematology parameters such as mean corpuscle volume. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.
Time Frame Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Overall Number of Participants Analyzed 14 16
Mean (Standard Deviation)
Unit of Measure: Femtoliter
Baseline; n=14, 16 Number Analyzed 14 participants 16 participants
99.1  (8.83) 97.8  (9.28)
Day 8; n=14, 15 Number Analyzed 14 participants 15 participants
0.1  (2.35) 0.3  (1.71)
Day 28; n=13, 16 Number Analyzed 13 participants 16 participants
1.2  (3.26) 0.3  (3.82)
Week 8; n=11, 16 Number Analyzed 11 participants 16 participants
0.3  (3.77) -0.3  (6.02)
Week 12; n=12, 14 Number Analyzed 12 participants 14 participants
1.1  (7.73) -1.5  (7.39)
Week 16; n=12, 16 Number Analyzed 12 participants 16 participants
0.3  (7.84) -2.2  (8.85)
Week 24; n=11, 15 Number Analyzed 11 participants 15 participants
-0.3  (8.25) -2.0  (10.36)
Week 32; n=11, 13 Number Analyzed 11 participants 13 participants
-1.0  (8.54) -2.4  (10.87)
Week 40; n=8, 12 Number Analyzed 8 participants 12 participants
2.5  (8.75) -0.7  (11.41)
Week 48; n=8, 13 Number Analyzed 8 participants 13 participants
2.0  (7.76) -1.0  (11.73)
Week 60; n=5, 12 Number Analyzed 5 participants 12 participants
1.4  (7.89) -1.2  (11.82)
Week 72; n=3, 4 Number Analyzed 3 participants 4 participants
0.3  (10.12) 2.3  (14.10)
Week 84; n=0, 1 Number Analyzed 0 participants 1 participants
18.0 [1]   (NA)
[1]
Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.
33.Secondary Outcome
Title Change From Baseline in Red Blood Cell Count
Hide Description Blood samples were collected for the analysis of hematology parameters such as RBC. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.
Time Frame Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)
Arm/Group Title DTG 50 mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Overall Number of Participants Analyzed 14 16
Mean (Standard Deviation)
Unit of Measure: Trillion cells per liter
Baseline; n=14, 16 Number Analyzed 14 participants 16 participants
4.09  (0.550) 4.09  (0.731)
Day 8; n=14, 15 Number Analyzed 14 participants 15 participants
0.00  (0.254) -0.04  (0.140)
Day 28; n=13, 16 Number Analyzed 13 participants 16 participants
-0.08  (0.309) -0.06  (0.318)
Week 8; n=11, 16 Number Analyzed 11 participants 16 participants
-0.14  (0.434) 0.12  (0.435)
Week 12; n=12, 14 Number Analyzed 12 participants 14 participants
-0.05  (0.493) 0.15  (0.477)
Week 16; n=12, 16 Number Analyzed 12 participants 16 participants
-0.03  (0.529) 0.13  (0.478)
Week 24; n=11, 15 Number Analyzed 11 participants 15 participants
0.02  (0.464) 0.18  (0.514)
Week 32; n=11, 13 Number Analyzed 11 participants 13 participants
-0.04  (0.467) 0.18  (0.504)
Week 40; n=8, 12 Number Analyzed 8 participants 12 participants
-0.08  (0.392) 0.09  (0.658)
Week 48; n=8, 13 Number Analyzed 8 participants 13 participants
-0.00  (0.334) 0.15  (0.625)
Week 60; n=5, 12 Number Analyzed 5 participants 12 participants
-0.06  (0.428) 0.28  (0.625)
Week 72; n=3, 4 Number Analyzed 3 participants 4 participants
-0.20  (0.173) 0.25  (0.759)
Week 84; n=0, 1 Number Analyzed 0 participants 1 participants
-0.60 [1]   (NA)
[1]
Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.
Time Frame Serious adverse events (SAEs) and non-serious AEs were collected in the time period from the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks).
Adverse Event Reporting Description SAEs and AEs were collected in members of Safety Population, comprised of all randomized participants who received at least one dose of study medication.
 
Arm/Group Title DTG 50mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Hide Arm/Group Description Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase. Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
All-Cause Mortality
DTG 50mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Affected / at Risk (%) Affected / at Risk (%)
Total   2/14 (14.29%)   0/16 (0.00%) 
Hide Serious Adverse Events
DTG 50mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Affected / at Risk (%) Affected / at Risk (%)
Total   5/14 (35.71%)   4/16 (25.00%) 
Cardiac disorders     
Coronary artery disease  1  1/14 (7.14%)  0/16 (0.00%) 
Cardiac arrest  1  1/14 (7.14%)  0/16 (0.00%) 
Gastrointestinal disorders     
Diarrhoea  1  1/14 (7.14%)  0/16 (0.00%) 
General disorders     
Cardiac death  1  1/14 (7.14%)  0/16 (0.00%) 
Chest pain  1  1/14 (7.14%)  0/16 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  0/14 (0.00%)  1/16 (6.25%) 
Infections and infestations     
Herpes zoster  1  0/14 (0.00%)  1/16 (6.25%) 
Perirectal abscess  1  0/14 (0.00%)  1/16 (6.25%) 
Pneumonia  1  1/14 (7.14%)  0/16 (0.00%) 
Injury, poisoning and procedural complications     
Multiple fractures  1  0/14 (0.00%)  1/16 (6.25%) 
Road traffic accident  1  0/14 (0.00%)  1/16 (6.25%) 
Pulmonary contusion  1  0/14 (0.00%)  1/16 (6.25%) 
Nervous system disorders     
Brain injury  1  0/14 (0.00%)  1/16 (6.25%) 
Renal and urinary disorders     
Renal failure acute  1  1/14 (7.14%)  0/16 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  1/14 (7.14%)  0/16 (0.00%) 
Respiratory failure  1  0/14 (0.00%)  1/16 (6.25%) 
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DTG 50mg BID Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase
Affected / at Risk (%) Affected / at Risk (%)
Total   11/14 (78.57%)   14/16 (87.50%) 
Blood and lymphatic system disorders     
Lymphadenopathy  1  3/14 (21.43%)  0/16 (0.00%) 
Haemorrhagic anaemia  1  0/14 (0.00%)  1/16 (6.25%) 
Cardiac disorders     
Cardiomyopathy  1  1/14 (7.14%)  0/16 (0.00%) 
Arrhythmia  1  1/14 (7.14%)  0/16 (0.00%) 
Eye disorders     
Dry eye  1  0/14 (0.00%)  1/16 (6.25%) 
Gastrointestinal disorders     
Diarrhoea  1  3/14 (21.43%)  2/16 (12.50%) 
Nausea  1  3/14 (21.43%)  2/16 (12.50%) 
Abdominal pain upper  1  2/14 (14.29%)  0/16 (0.00%) 
Vomiting  1  1/14 (7.14%)  2/16 (12.50%) 
Abdominal pain  1  1/14 (7.14%)  0/16 (0.00%) 
Constipation  1  1/14 (7.14%)  0/16 (0.00%) 
Dry mouth  1  0/14 (0.00%)  1/16 (6.25%) 
Flatulence  1  0/14 (0.00%)  1/16 (6.25%) 
Food poisoning  1  0/14 (0.00%)  1/16 (6.25%) 
Gingival bleeding  1  0/14 (0.00%)  1/16 (6.25%) 
Odynophagia  1  1/14 (7.14%)  0/16 (0.00%) 
Proctalgia  1  1/14 (7.14%)  0/16 (0.00%) 
Rectal fissure  1  1/14 (7.14%)  0/16 (0.00%) 
General disorders     
Asthenia  1  1/14 (7.14%)  0/16 (0.00%) 
Chest pain  1  2/14 (14.29%)  0/16 (0.00%) 
Fatigue  1  1/14 (7.14%)  0/16 (0.00%) 
Injection site induration  1  1/14 (7.14%)  0/16 (0.00%) 
Injection site pain  1  0/14 (0.00%)  1/16 (6.25%) 
Pyrexia  1  2/14 (14.29%)  0/16 (0.00%) 
Chest discomfort  1  1/14 (7.14%)  0/16 (0.00%) 
Local swelling  1  1/14 (7.14%)  0/16 (0.00%) 
Pain  1  0/14 (0.00%)  1/16 (6.25%) 
Infections and infestations     
Upper respiratory tract infection  1  1/14 (7.14%)  3/16 (18.75%) 
Influenza  1  1/14 (7.14%)  1/16 (6.25%) 
Otitis media  1  1/14 (7.14%)  0/16 (0.00%) 
Urinary tract infection  1  1/14 (7.14%)  0/16 (0.00%) 
Vaginal abscess  1  0/14 (0.00%)  1/16 (6.25%) 
Herpes zoster  1  0/14 (0.00%)  2/16 (12.50%) 
Pneumonia  1  1/14 (7.14%)  1/16 (6.25%) 
Abscess  1  0/14 (0.00%)  1/16 (6.25%) 
Fungal infection  1  0/14 (0.00%)  1/16 (6.25%) 
Gastritis viral  1  1/14 (7.14%)  0/16 (0.00%) 
Genital herpes  1  0/14 (0.00%)  1/16 (6.25%) 
Helicobacter infection  1  0/14 (0.00%)  1/16 (6.25%) 
Syphilis  1  1/14 (7.14%)  0/16 (0.00%) 
Urethritis  1  1/14 (7.14%)  0/16 (0.00%) 
Viral upper respiratory tract infection  1  0/14 (0.00%)  1/16 (6.25%) 
Injury, poisoning and procedural complications     
Fall  1  1/14 (7.14%)  0/16 (0.00%) 
Thermal burn  1  1/14 (7.14%)  0/16 (0.00%) 
Excoriation  1  0/14 (0.00%)  1/16 (6.25%) 
Investigations     
Blood creatinine increased  1  1/14 (7.14%)  1/16 (6.25%) 
Metabolism and nutrition disorders     
Dehydration  1  1/14 (7.14%)  0/16 (0.00%) 
Musculoskeletal and connective tissue disorders     
Muscle spasms  1  1/14 (7.14%)  0/16 (0.00%) 
Musculoskeletal chest pain  1  1/14 (7.14%)  0/16 (0.00%) 
Neck pain  1  1/14 (7.14%)  0/16 (0.00%) 
Pain in extremity  1  0/14 (0.00%)  1/16 (6.25%) 
Arthralgia  1  0/14 (0.00%)  2/16 (12.50%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Squamous cell carcinoma of skin  1  1/14 (7.14%)  0/16 (0.00%) 
Nervous system disorders     
Headache  1  3/14 (21.43%)  1/16 (6.25%) 
Dizziness  1  2/14 (14.29%)  0/16 (0.00%) 
Syncope  1  1/14 (7.14%)  0/16 (0.00%) 
Neuropathy peripheral  1  0/14 (0.00%)  2/16 (12.50%) 
Amnesia  1  0/14 (0.00%)  1/16 (6.25%) 
Presyncope  1  1/14 (7.14%)  0/16 (0.00%) 
Radiculopathy  1  0/14 (0.00%)  1/16 (6.25%) 
Psychiatric disorders     
Anxiety  1  1/14 (7.14%)  0/16 (0.00%) 
Depression  1  1/14 (7.14%)  3/16 (18.75%) 
Libido decreased  1  1/14 (7.14%)  0/16 (0.00%) 
Mood altered  1  0/14 (0.00%)  1/16 (6.25%) 
Renal and urinary disorders     
Nephrolithiasis  1  1/14 (7.14%)  0/16 (0.00%) 
Nephropathy toxic  1  0/14 (0.00%)  1/16 (6.25%) 
Renal failure acute  1  0/14 (0.00%)  1/16 (6.25%) 
Reproductive system and breast disorders     
Breast enlargement  1  0/14 (0.00%)  1/16 (6.25%) 
Erectile dysfunction  1  0/14 (0.00%)  2/16 (12.50%) 
Breast pain  1  1/14 (7.14%)  0/16 (0.00%) 
Ejaculation delayed  1  0/14 (0.00%)  1/16 (6.25%) 
Pelvic pain  1  1/14 (7.14%)  0/16 (0.00%) 
Peyronie's disease  1  0/14 (0.00%)  1/16 (6.25%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  2/14 (14.29%)  1/16 (6.25%) 
Chronic obstructive pulmonary disease  1  1/14 (7.14%)  0/16 (0.00%) 
Cough  1  2/14 (14.29%)  0/16 (0.00%) 
Nasal discomfort  1  1/14 (7.14%)  0/16 (0.00%) 
Sinus congestion  1  0/14 (0.00%)  1/16 (6.25%) 
Skin and subcutaneous tissue disorders     
Macule  1  0/14 (0.00%)  1/16 (6.25%) 
Skin irritation  1  1/14 (7.14%)  0/16 (0.00%) 
Rash  1  2/14 (14.29%)  1/16 (6.25%) 
Alopecia  1  1/14 (7.14%)  0/16 (0.00%) 
Dermatitis  1  0/14 (0.00%)  1/16 (6.25%) 
Dry skin  1  0/14 (0.00%)  1/16 (6.25%) 
Pruritus  1  0/14 (0.00%)  1/16 (6.25%) 
Rash pruritic  1  0/14 (0.00%)  1/16 (6.25%) 
Vascular disorders     
Hypertension  1  1/14 (7.14%)  0/16 (0.00%) 
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01568892    
Other Study ID Numbers: 116529
First Submitted: March 29, 2012
First Posted: April 2, 2012
Results First Submitted: August 15, 2013
Results First Posted: February 19, 2014
Last Update Posted: July 2, 2018