A Trial Comparing GSK1349572 50mg Plus Abacavir/Lamivudine Once Daily to Atripla (Also Called The SINGLE Trial)

• ClinicalTrials.gov Identifier: NCT01263015
• Recruitment Status: Completed
• First Posted: December 20, 2010
• Results First Posted: July 2, 2014
• Last Update Posted: April 4, 2018
• Sponsor: ViiV Healthcare
• Collaborators: Shionogi; GlaxoSmithKline
• Information provided by (Responsible Party): ViiV Healthcare

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Infection, Human Immunodeficiency Virus I
• Interventions: Drug: Dolutegravir; Drug: Atripla; Drug: Abacavir/Lamivudine; Drug: Abacavir/Lamivudine Placebo; Drug: Dolutegravir placebo; Drug: Atripla placebo
• Enrollment: 844

Participant Flow

Recruitment Details	Study consisted of 96 weeks double-blind phase, followed by a 48 week open-label phase.
Pre-assignment Details	A total of 844 participants (par.) were randomized (1:1) to one of the two treatment arms. Of these, 833 par. received at least one dose of study medication. Of the 11 par. who were randomized but not treated with investigational product, 7 par. withdrew consent, 3 par. were randomized in error, and 1 par. was lost to follow-up.

Arm/Group Title	DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily	EFV/TDF/FTC 600/200/300 mg Once Daily
Arm/Group Description	During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks.	During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks.
Period Title: Double-blind Phase: 96 Weeks Duration
Started	414	419
Completed	342	310
Not Completed	72	109
Reason Not Completed
Adverse Event	13	48
Lack of Efficacy	18	14
Protocol Violation	14	12
Lost to Follow-up	17	18
Withdrawal by Subject	9	15
Physician Decision	1	2
Period Title: Open-label Phase: 48 Weeks Duration
Started	341	309
Completed	317	278
Not Completed	24	31
Reason Not Completed
Adverse Event	3	10
Lack of Efficacy	7	2
Protocol Violation	3	2
Lost to Follow-up	8	8
Physician Decision	0	2
Withdrawal by Subject	3	7

Baseline Characteristics

Arm/Group Title		DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily	EFV/TDF/FTC 600/200/300 mg Once Daily	Total
Arm/Group Description		During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.	During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.	Total of all reporting groups
Overall Number of Baseline Participants		414	419	833
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	414 participants	419 participants	833 participants
		36.5 (10.74)	36.4 (10.43)	36.4 (10.58)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	414 participants	419 participants	833 participants
	Female	67 16.2%	63 15.0%	130 15.6%
	Male	347 83.8%	356 85.0%	703 84.4%
Race/Ethnicity, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	414 participants	419 participants	833 participants
African American (Af Am)/African Heritage (Af Ht)		98	99	197
American Indian (AI) or Alaska Native (Nat)		13	17	30
Asian		9	9	18
White		284	285	569
Af Am/Af Ht & AI or Alaska Native		0	1	1
Af Am/Af Ht & Nat Hawaiian/other Pacific Islander		0	1	1
Af Am/Af Ht & White		3	2	5
American Indian or Alaska Native & White		6	4	10
Asian & White		1	0	1
Missing		0	1	1

Outcome Measures

1. Primary Outcome

Title	Proportion of Subjects Responding Based on Plasma HIV-1 RNA <50 c/mL at Week 48
Description	The percentage of participants with plasma HIV-1 RNA <50 c/mL at Week 48 was assessed. Plasma samples were collected for the quantitative assessment of HIV-1 RNA based on the Missing, Switch, or Discontinuation equals Failure (MSDF) algorithm,as codified by the Food and Drug Administration's Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigationl product prior to the visit window) as non-responders, as well as participants who switched their concomitant antiretroviral therapy (ART) in certain scenarios. Since changes in ART were not permitted in this protocol, all such participants who changed ART were to be considered non-responders. Otherwise, virologic success or failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the visit of interest window.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

Intent-to-Treat-Exposed (ITT-E) Population: all randomized participants who received at least one dose of study medication

Arm/Group Title	DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily	EFV/TDF/FTC 600/200/300 mg Once Daily
Arm/Group Description:	During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.	During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
Overall Number of Participants Analyzed	414	419
Measure Type: Number; Unit of Measure: Percentage of participants
	88	81

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily, EFV/TDF/FTC 600/200/300 mg Once Daily
	Comments	[Not Specified]
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority could be concluded if the lower bound of a two-sided 95% confidence interval for the difference (DTG + ABC/3TC minus EFV/TDF/FTC) in percentages between the two treatment arms was > -10%.
Statistical Test of Hypothesis	P-Value	0.003
	Comments	P-value is for the test of superiority.
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	7.3
	Confidence Interval	(2-Sided) 95%; 2.3 to 12.2
	Estimation Comments	The estimated value reflects the percentage on DTG + ABC/3TC minus the percentage on EFV/TDF/FTC.

2. Secondary Outcome

Title	Time to Viral Suppression (<50 c/mL)
Description	Viral suppression is defined as the first viral load value<50 c/mL. The Kaplan-Meier method was used to estimate time to viral suppression, defined as the time from the first dose of study treatment until the first viral load value <50 c/mL was reached. Participants who withdrew for any reason without having suppressed prior to the analysis were censored.
Time Frame	From Baseline until Week 144) (average of 877.4 days for DTG; average of 788.8 study days for EFV/TDF/FTC)

Outcome Measure Data

Analysis Population Description

ITT-E Population

Arm/Group Title	DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily	EFV/TDF/FTC 600/200/300 mg Once Daily
Arm/Group Description:	During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.	During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
Overall Number of Participants Analyzed	414	419
Median (95% Confidence Interval); Unit of Measure: Days
	28; (28.0 to 29.0)	84; (83.0 to 84.0)

3. Secondary Outcome

Title	Percentage of Participants With Plasma Human Immunodeficiency Virus -1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 96 and Week 144
Description	The percentage of participants with plasma HIV-1 RNA <50 c/mL at Week 96 and Week 144 was assessed. Plasma samples were collected for the quantitative assessment of HIV-1 RNA based on the Missing, Switch, or Discontinuation equals Failure (MSDF) algorithm,as codified by the Food and Drug Administration's Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigationl product prior to the visit window) as non-responders, as well as participants who switched their concomitant antiretroviral therapy (ART) in certain scenarios. Since changes in ART were not permitted in this protocol, all such participants who changed ART were to be considered non-responders. Otherwise, virologic success or failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the visit of interest window.
Time Frame	Week 96 and Week 144

Outcome Measure Data

Analysis Population Description

Intent-to-Treat-Exposed (ITT-E) Population: all randomized participants who received at least one dose of study medication

Arm/Group Title	DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily	EFV/TDF/FTC 600/200/300 mg Once Daily
Arm/Group Description:	During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.	During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
Overall Number of Participants Analyzed	414	419
Measure Type: Number; Unit of Measure: Percentage of participants
Week 96	77	70
Week 144	71	63

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily, EFV/TDF/FTC 600/200/300 mg Once Daily
	Comments	[Not Specified]
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority could be concluded if the lower bound of a two-sided 95% confidence interval for the difference (DTG + ABC/3TC minus EFV/TDF/FTC) in percentages between the two treatment arms was > -10%.
Statistical Test of Hypothesis	P-Value	0.016
	Comments	P-value is for the test of superiority.
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	7.1
	Confidence Interval	(2-Sided) 95%; 1.2 to 13.1
	Estimation Comments	Week 96:The estimated value reflects the percentage on DTG + ABC/3TC minus the percentage on EFV/TDF/FTC.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily, EFV/TDF/FTC 600/200/300 mg Once Daily
	Comments	[Not Specified]
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority could be concluded if the lower bound of a two-sided 95% confidence interval for the difference (DTG + ABC/3TC minus EFV/TDF/FTC) in percentages between the two treatment arms was >-10%.
Statistical Test of Hypothesis	P-Value	0.010
	Comments	P-value is for the test of superiority.
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	8.3
	Confidence Interval	(2-Sided) 95%; 1.9 to 14.6
	Estimation Comments	Week 144:Estimated value reflects the percentage on DTG + ABC/3TC minus the percentage on EFV/TDF/FTC.

4. Secondary Outcome

Title	Number of Participants With a Confirmed Plasma HIV-1 RNA Level >=1000 c/mL at or After Week 16 and Before Week 24, or a Confirmed Plasma HIV-1 RNA Level >=200 c/mL at or After Week 24
Description	Data are presented as Kaplan Meier estimates of virologic failure (VF), defined as a confirmed plasma HIV-1 RNA level >=1000 c/mL at or after Week 16 and before Week 24, or a confirmed plasma HIV-1 RNA level >=200 c/mL at or after Week 24. A plasma HIV-1 RNA value was considered to be confirmed failure if a consecutive measurement satisfied the same failure criterion. The number of participants who experienced autoimmune deficiency syndrome (AIDS) Clinical Trials Group (ACTG) VFs was measured. For participants who withdrew from the study/were not documented to have reached confirmed VF at the cut off date of the Week 48 analysis, time to VF was to be censored at the planned visit week of the last measured plasma HIV-1 RNA sample. Data for participants who missed three consecutive scheduled plasma HIV-1 RNA measurements were to be censored at the planned visit week of the last assessment prior to the 3 consecutive missed visits.
Time Frame	From Baseline until Week 144) (average of 877.4 days for DTG; average of 788.8 study days for EFV/TDF/FTC)

Outcome Measure Data

Analysis Population Description

ITT-E Population

Arm/Group Title	DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily	EFV/TDF/FTC 600/200/300 mg Once Daily
Arm/Group Description:	During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.	During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
Overall Number of Participants Analyzed	414	419
Measure Type: Number; Unit of Measure: Participants
ACTG virologic failures	11	8
Censored participants	403	411

5. Secondary Outcome

Title	Change From Baseline in Plasma HIV-1 RNA at Weeks 2, 4, 8, 12, 16, 24, 32, 40,48, 60, 72, 84, 96, 108, 120, 132 and 144
Description	Blood samples were collected for the measurement of HIV-1 RNA in plasma. Changes from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants available at the indicated time points were assessed (represented by n=X, X in the category titles).
Time Frame	Baseline and at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144

Outcome Measure Data

Analysis Population Description

ITT-E Population

Arm/Group Title	DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily	EFV/TDF/FTC 600/200/300 mg Once Daily
Arm/Group Description:	During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.	During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
Overall Number of Participants Analyzed	414	419
Mean (Standard Deviation); Unit of Measure: log10 copies/mL
Week 2, n=387, 376	-2.46 (0.49)	-1.96 (0.46)
Week 4, n=404, 391	-2.88 (0.58)	-2.25 (0.52)
Week 8, n=395, 386	-2.99 (0.64)	-2.60 (0.60)
Week 12, n=394, 377	-3.01 (0.70)	-2.85 (0.63)
Week 16, n=386, 366	-3.03 (0.66)	-2.98 (0.65)
Week 24, n=389, 364	-3.05 (0.69)	-3.01 (0.76)
Week 32, n=380, 355	-3.04 (0.70)	-3.05 (0.72)
Week 40, n=370, 345	-3.05 (0.68)	-3.04 (0.70)
Week 48, n=370, 343	-3.03 (0.69)	-3.04 (0.69)
Week 60, n=360, 330	-3.03 (0.67)	-3.05 (0.69)
Week 72, n=354, 320	-3.03 (0.70)	-3.06 (0.70)
Week 84, n=353, 314	-3.02 (0.70)	-3.07 (0.68)
Week 96, n=345, 310	-2.99 (0.73)	-3.06 (0.68)
Week 108, n=340, 300	-3.01 (0.71)	-3.08 (0.67)
Week 120, n=333, 289	-3.00 (0.77)	-3.07 (0.67)
Week 132, n=323, 284	-3.03 (0.68)	-3.06 (0.67)
Week 144, n=313,269	-3.02 (0.72)	-3.04 (0.69)

6. Secondary Outcome

Title	Change From Baseline in CD4+ Cell Counts at Week 144
Description	Cluster of differentiation (CD4) lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immunocompromise. The CD4 count is used to stage the patient's disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start antiretroviral therapy. Change from Baseline was calculated as the Week 144 value minus the Baseline value. The least squares mean is the estimated mean change from Baseline in CD4+ cell counts at Week 144 calculated from a repeated measures model including the following covariates: treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, treatment*visit interaction, Baseline HIV-1 RNA*visit interaction, and Baseline CD4+ cell count*visit interaction. No assumptions were made about the correlations between a participant's readings of CD4+, i.e., the correlation matrix for within-participant errors is unstructured.
Time Frame	Baseline and Week 144

Outcome Measure Data

Analysis Population Description

ITT-E Population

Arm/Group Title	DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily	EFV/TDF/FTC 600/200/300 mg Once Daily
Arm/Group Description:	During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.	During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
Overall Number of Participants Analyzed	414	419
Least Squares Mean (Standard Deviation); Unit of Measure: cells per millimeters cubed (cells/mm^3)
	378.48 (10.99)	331.57 (11.59)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily, EFV/TDF/FTC 600/200/300 mg Once Daily
	Comments	[Not Specified]
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Adjusted mean is the estimated mean change from baseline (BL) in CD4 + Cell Count at Week 144 in each arm calculated from a repeated measures model including the following covariates: treatment, visit, BL plasma HIV-1 RNA, BL CD4 cell count, treatment*visit interaction, BL HIV-1 RNA*visit interaction and BL CD4 cell count*visit interaction. No assumptions were made about the correlations between a par.'s readings of CD4 i.e. the correlation matrix for within-subject errors is unstructured.
Statistical Test of Hypothesis	P-Value	0.003
	Comments	P-value is for the test of superiority.
	Method	Repeated Measure Mixed Model
	Comments	[Not Specified]

7. Secondary Outcome

Title	Change From Baseline in CD4+ Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144
Description	CD4 lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immunocompromise. The CD4 count is used to stage the patient's disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start antiretroviral therapy. Change from Baseline was calculated as the value at Indicated visit minus the Baseline value. Only those participants available at the indicated time points were assessed (represented by n=X, X in the category titles).
Time Frame	Baseline and Week 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144

Outcome Measure Data

Analysis Population Description

ITT-E Population

Arm/Group Title	DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily	EFV/TDF/FTC 600/200/300 mg Once Daily
Arm/Group Description:	During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.	During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
Overall Number of Participants Analyzed	414	419
Mean (Standard Deviation); Unit of Measure: cells per millimeters cubed (cells/mm^3)
Week 4, n=404,390	117.6 (114.51)	80.9 (112.43)
Week 8, n=396,382	164.6 (129.98)	124.4 (124.50)
Week 12, n=394,378	187.5 (157.46)	153.0 (131.91)
Week 16, n=386,366	214.7 (173.35)	174.1 (132.02)
Week 24, n=388,361	216.9 (162.89)	177.8 (147.72)
Week 32, n=380,353	250.5 (172.06)	208.1 (152.13)
Week 40, n=364,347	265.5 (187.81)	216.2 (158.49)
Week 48, n=368,344	267.5 (192.30)	209.5 (164.37)
Week 60, n=359,330	271.3 (188.05)	235.3 (171.98)
Week 72, n=354,319	306.1 (202.02)	269.6 (180.04)
Week 84, n=352,314	315.2 (197.92)	272.1 (172.28)
Week 96, n=343,309	322.6 (205.35)	286.0 (195.70)
Week 108, n=339,300	349.3 (218.76)	298.9 (188.41)
Week 120, n=332,287	347.0 (234.96)	311.0 (198.79)
Week 132, n=323,283	377.9 (205.78)	327.2 (175.31)
Week 144, n=313,270	379.5 (221.17)	333.3 (189.25)

8. Secondary Outcome

Title	Number of Participants With the Indicated Post-baseline HIV-associated Conditions and Progression, Excluding Recurrences at Week 144
Description	Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CDC CAT A at Baseline (BS) to a CDC CAT C event (EV); CDC CAT B at BS to a CDC CAT C EV; CDC CAT C at BS to a new CDC CAT C EV; or CDC CAT A, B, or C at BS to death.
Time Frame	From Baseline until Week 144

Outcome Measure Data

Analysis Population Description

ITT-E Population

Arm/Group Title	DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily	EFV/TDF/FTC 600/200/300 mg Once Daily
Arm/Group Description:	During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.	During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
Overall Number of Participants Analyzed	414	419
Measure Type: Number; Unit of Measure: Participants
Week 144, Any category condition	17	24
Week 144, Any Category B condition	12	17
Week 144, Any Category C condition	5	6
Week 144, Any death	0	2
Week 144, Progression from CAT A to CAT C	4	4
Week 144, Progression from CAT C to new CAT C	1	2
Week 144, Progression from CAT A, B, or C to death	0	2

9. Secondary Outcome

Title	Number of Participants With the Indicated Grade 1 to 4 Clinical and Hematology Toxicities at Week144
Description	All Grade 1 to 4 post-Baseline-emergent chemistry toxicities included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), asparate aminotransferase (AST), carbon dioxide (CO2) content/bicarbonate, cholesterol, creatine kinase (CK), creatinine, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphorus inorganic, total bilirubin, and triglycerides. All Grade 1 to 4 post-Baseline-emergent hematology toxities included hemoglobin, platelet count, total neutrophils, and white blood cell count. The Division of AIDS (DAIDS) defined toxicity grades as follows: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening; Grade 5, death.
Time Frame	From Baseline until Week 144

Outcome Measure Data

Analysis Population Description

Safety Population: all participants who received at least one dose of investigational product

Arm/Group Title	DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily	EFV/TDF/FTC 600/200/300 mg Once Daily
Arm/Group Description:	During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.	During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
Overall Number of Participants Analyzed	414	419
Measure Type: Number; Unit of Measure: Participants
Week 144, ALT	62	81
Week 144, Albumin	0	1
Week 144, ALP	17	53
Week 144, AST	77	85
Week 144, CO2 content/bicarbonate	135	134
Week 144, Cholesterol	156	140
Week 144, CK	91	79
Week 144, Creatinine	17	6
Week 144, Hyperglycaemia	121	105
Week 144, Hyperkalemia	4	12
Week 144, Hypernatremia	11	9
Week 144, Hypoglycaemia	24	21
Week 144, Hypokalemia	38	21
Week 144, Hyponatremia	63	86
Week 144, LDL cholesterol calculation	124	111
Week 144, Lipase	111	110
Week 144, Phosphorus, inorganic	109	134
Week 144, Total bilirubin	22	4
Week 144, Triglycerides	11	11
Week 144, Hemoglobin	7	11
Week 144, Platelet count	20	19
Week 144, Total neutrophils	70	80
Week 144, White Blood Cell count	9	18

10. Secondary Outcome

Title	Number of Participants With the Indicated Genotypic Resistance With Virological Failure (VF) Through 144
Description	Whole blood samples were collected from participants to provide plasma for storage samples for potential viral genotypic and phenotypic analyses. Participants with confirmed virological failure (confirmed HIV-1 RNA >=50 copies/mL throughout the study and/or confirmed HIV-1 RNA >=200 copies/mL at Week 144) had plasma samples tested for HIV-1 RT genotype and HIV-1 integrase genotype from Baseline samples and from samples collected at the time of virological failure. Genotype testing was conducted at Day 1 and at the time of suspected protocol-defined virological failure (PDVF). A genotyping assessment was made of change across all amino acids within the integrase (IN)-encoding region, with particular attention paid to specific amino acid changes associated with the development of resistance to RAL, ELV, or DTG.
Time Frame	Through Week 144

Outcome Measure Data

Analysis Population Description

PDVF Genotypic Population: all participants in the ITT-E Population with available on-treatment genotypic resistance data at the time of PDVF

Arm/Group Title	DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily	EFV/TDF/FTC 600/200/300 mg Once Daily
Arm/Group Description:	During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.	During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
Overall Number of Participants Analyzed	26	16
Measure Type: Number; Unit of Measure: Participants
Week 144, RT mutation K65K/R	0	1
Week 144, RT mutation K101E	0	1
Week 144, RT mutation K103K/N	0	2
Week 144, RT mutation K103N	0	2
Week 144, RT mutation G190G/A	0	2

11. Secondary Outcome

Title	Change From Baseline in the Symptom Bother Score (SBS) at Week 4 Through Week 48
Description	The Symptom Distress Module (SDM) is a 20-item, self-reported questionnaire measuring the presence/perceived distress linked to symptoms associated with HIV/its treatments. Developed with support from the AIDS Clinical Trials Group of the U.S. National Institute of Allergy and Infectious Diseases, it has demonstrated construct validity and has shown strong associations with physical/mental health summary scores and with disease severity. The SDM consists of 2 main scores: symptom count and the SBS, ranging from 0 (best) to 80 (worst) and based on the degree of bother that each symptom present posed. The SBS was calculated by adding the 20 individual bother item scores, which were calculated as: 0, "I do not have this symptom"; 1, "It doesn't bother me"; 2, "It bothers me a little"; 3, "It bothers me"; 4, "It bothers me a lot." Estimates are calculated from an analysis of covariance (ANCOVA) model adjusting for age, sex, race, Baseline (BL) viral load, BL CD4+ cell count, and BL SBS.
Time Frame	Baseline and Week 4 through 48

Outcome Measure Data

Analysis Population Description

ITT-E Population. Participants with missing bother item scores at Week 4 had their last observation carried forward (LOCF). Only those participants contributing to the model (i.e., without missing response variables after LOCF or covariates) were analyzed.

Arm/Group Title	DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily	EFV/TDF/FTC 600/200/300 mg Once Daily
Arm/Group Description:	During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.	During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
Overall Number of Participants Analyzed	394	393
Least Squares Mean (Standard Error); Unit of Measure: Scores on a scale
	-1.818 (0.3849)	-1.246 (0.3854)

Adverse Events

Time Frame	Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to Week 144 (average of 877.4 study days for DTG; average of 788.8 study days for EFV/TDF/FTC).
Adverse Event Reporting Description	SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
Arm/Group Title	DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily	EFV/TDF/FTC 600/200/300 mg Once Daily
Arm/Group Description	During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.	During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
All-Cause Mortality
	DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily	EFV/TDF/FTC 600/200/300 mg Once Daily
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily	EFV/TDF/FTC 600/200/300 mg Once Daily
	Affected / at Risk (%)	Affected / at Risk (%)
Total	65/414 (15.70%)	60/419 (14.32%)
Blood and lymphatic system disorders
Anaemia † 1	0/414 (0.00%)	1/419 (0.24%)
Disseminated intravascular coagulation † 1	0/414 (0.00%)	1/419 (0.24%)
Febrile neutropenia † 1	1/414 (0.24%)	0/419 (0.00%)
Cardiac disorders
Atrial fibrillation † 1	0/414 (0.00%)	1/419 (0.24%)
Atrial flutter † 1	0/414 (0.00%)	1/419 (0.24%)
Cardiac failure congestive † 1	1/414 (0.24%)	0/419 (0.00%)
Coronary artery disease † 1	0/414 (0.00%)	1/419 (0.24%)
Angina unstable † 1	1/414 (0.24%)	0/419 (0.00%)
Cardiac failure † 1	1/414 (0.24%)	0/419 (0.00%)
Pericarditis † 1	1/414 (0.24%)	0/419 (0.00%)
Right ventricular failure † 1	1/414 (0.24%)	0/419 (0.00%)
Endocrine disorders
Basedow's disease † 1	1/414 (0.24%)	0/419 (0.00%)
Gastrointestinal disorders
Food poisoning † 1	1/414 (0.24%)	0/419 (0.00%)
Abdominal pain upper † 1	1/414 (0.24%)	0/419 (0.00%)
Pancreatitis acute † 1	1/414 (0.24%)	0/419 (0.00%)
Rectal haemorrhage † 1	0/414 (0.00%)	1/419 (0.24%)
General disorders
Non-cardiac chest pain † 1	1/414 (0.24%)	0/419 (0.00%)
Chest pain † 1	1/414 (0.24%)	1/419 (0.24%)
Adverse drug reaction † 1	1/414 (0.24%)	0/419 (0.00%)
Systemic inflammatory response sydrome † 1	0/414 (0.00%)	1/419 (0.24%)
Hepatobiliary disorders
Cholelithiasis † 1	0/414 (0.00%)	1/419 (0.24%)
Immune system disorders
Hypersensitivity † 1	0/414 (0.00%)	1/419 (0.24%)
Drug hypersensitivity † 1	1/414 (0.24%)	0/419 (0.00%)
Anaphylactic reaction † 1	0/414 (0.00%)	1/419 (0.24%)
Infections and infestations
Pneumonia † 1	2/414 (0.48%)	2/419 (0.48%)
Bronchitis † 1	1/414 (0.24%)	3/419 (0.72%)
Syphilis † 1	2/414 (0.48%)	0/419 (0.00%)
Appendicitis † 1	4/414 (0.97%)	2/419 (0.48%)
Bacteraemia † 1	0/414 (0.00%)	1/419 (0.24%)
Cellulitis † 1	1/414 (0.24%)	2/419 (0.48%)
Gastroenteritis † 1	0/414 (0.00%)	1/419 (0.24%)
Infected dermal cyst † 1	1/414 (0.24%)	0/419 (0.00%)
Meningitis † 1	1/414 (0.24%)	0/419 (0.00%)
Meningitis cryptococcal † 1	0/414 (0.00%)	1/419 (0.24%)
Mycobacterium avium complex infection † 1	1/414 (0.24%)	0/419 (0.00%)
Neurosyphilis † 1	1/414 (0.24%)	0/419 (0.00%)
Pneumococcal sepsis † 1	0/414 (0.00%)	1/419 (0.24%)
Postoperative wound infection † 1	1/414 (0.24%)	0/419 (0.00%)
Scrotal abscess † 1	0/414 (0.00%)	1/419 (0.24%)
Sepsis † 1	0/414 (0.00%)	1/419 (0.24%)
Septic shock † 1	0/414 (0.00%)	1/419 (0.24%)
Staphylococcal abscess † 1	0/414 (0.00%)	1/419 (0.24%)
Subcutaneous abscess † 1	0/414 (0.00%)	3/419 (0.72%)
Systemic candida † 1	0/414 (0.00%)	1/419 (0.24%)
Toxoplasmosis † 1	1/414 (0.24%)	0/419 (0.00%)
Tuberculosis † 1	1/414 (0.24%)	0/419 (0.00%)
Viral infection † 1	1/414 (0.24%)	0/419 (0.00%)
AIDS dementia complex † 1	0/414 (0.00%)	1/419 (0.24%)
Cellulitis pharyngeal † 1	0/414 (0.00%)	1/419 (0.24%)
Empyema † 1	1/414 (0.24%)	0/419 (0.00%)
Haematoma infection † 1	1/414 (0.24%)	0/419 (0.00%)
Human herpesvirus 6 infection † 1	1/414 (0.24%)	0/419 (0.00%)
Lower respiratory tract infection † 1	1/414 (0.24%)	0/419 (0.00%)
Paronychia † 1	1/414 (0.24%)	0/419 (0.00%)
Pneumonia bacterial † 1	0/414 (0.00%)	1/419 (0.24%)
Pneumonia pneumococcal † 1	1/414 (0.24%)	0/419 (0.00%)
Pyelonephritis † 1	0/414 (0.00%)	1/419 (0.24%)
Rectal abscess † 1	1/414 (0.24%)	0/419 (0.00%)
Sinusitis † 1	0/414 (0.00%)	1/419 (0.24%)
Viral upper respiratory tract infection † 1	0/414 (0.00%)	1/419 (0.24%)
Wound infection staphylococcal † 1	1/414 (0.24%)	0/419 (0.00%)
Injury, poisoning and procedural complications
Foot fracture † 1	1/414 (0.24%)	1/419 (0.24%)
Intentional overdose † 1	2/414 (0.48%)	0/419 (0.00%)
Head injury † 1	1/414 (0.24%)	0/419 (0.00%)
Humerus fracture † 1	1/414 (0.24%)	1/419 (0.24%)
Jaw fracture † 1	1/414 (0.24%)	0/419 (0.00%)
Overdose † 1	0/414 (0.00%)	2/419 (0.48%)
Road traffic accident † 1	1/414 (0.24%)	0/419 (0.00%)
Subdural haematoma † 1	1/414 (0.24%)	0/419 (0.00%)
Vascular pseudoaneurysm † 1	0/414 (0.00%)	1/419 (0.24%)
Acetabulum fracture † 1	0/414 (0.00%)	1/419 (0.24%)
Brain contusion † 1	1/414 (0.24%)	0/419 (0.00%)
Chemical burn of skin † 1	1/414 (0.24%)	0/419 (0.00%)
Facial bones fracture † 1	1/414 (0.24%)	0/419 (0.00%)
Forearm fracture † 1	0/414 (0.00%)	1/419 (0.24%)
Lower limb fracture † 1	0/414 (0.00%)	1/419 (0.24%)
Lumbar vertebral fracture † 1	0/414 (0.00%)	1/419 (0.24%)
Radius fracture † 1	0/414 (0.00%)	1/419 (0.24%)
Spinal fracture † 1	0/414 (0.00%)	1/419 (0.24%)
Tendon rupture † 1	0/414 (0.00%)	1/419 (0.24%)
Ulna fracture † 1	1/414 (0.24%)	0/419 (0.00%)
Metabolism and nutrition disorders
Type 2 diabetes mellitus † 1	1/414 (0.24%)	0/419 (0.00%)
Diabetes mellitus † 1	1/414 (0.24%)	0/419 (0.00%)
Hypovolaemia † 1	1/414 (0.24%)	0/419 (0.00%)
Musculoskeletal and connective tissue disorders
Myalgia † 1	1/414 (0.24%)	0/419 (0.00%)
Osteoarthritis † 1	1/414 (0.24%)	0/419 (0.00%)
Tendon disorder † 1	1/414 (0.24%)	0/419 (0.00%)
Rotator cuff syndrome † 1	0/414 (0.00%)	2/419 (0.48%)
Intervertebral disc protrusion † 1	1/414 (0.24%)	0/419 (0.00%)
Osteonecrosis † 1	1/414 (0.24%)	0/419 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer † 1	0/414 (0.00%)	1/419 (0.24%)
Colon cancer † 1	1/414 (0.24%)	1/419 (0.24%)
Hodgkin's disease † 1	0/414 (0.00%)	1/419 (0.24%)
Pancoast's tumour † 1	0/414 (0.00%)	1/419 (0.24%)
Pleomorphic adenoma † 1	1/414 (0.24%)	0/419 (0.00%)
Transitional cell carcinoma † 1	1/414 (0.24%)	0/419 (0.00%)
Nervous system disorders
Cerebrovascular accident † 1	1/414 (0.24%)	1/419 (0.24%)
Carpal tunnel syndrome † 1	1/414 (0.24%)	0/419 (0.00%)
Convulsion † 1	0/414 (0.00%)	1/419 (0.24%)
Grand mal convulsion † 1	1/414 (0.24%)	0/419 (0.00%)
Sciatica † 1	0/414 (0.00%)	2/419 (0.48%)
Syncope † 1	0/414 (0.00%)	3/419 (0.72%)
Coma † 1	1/414 (0.24%)	0/419 (0.00%)
Ischaemic stroke † 1	1/414 (0.24%)	0/419 (0.00%)
VIIth nerve paralysis † 1	0/414 (0.00%)	1/419 (0.24%)
Vasogenic cerebral oedema † 1	1/414 (0.24%)	0/419 (0.00%)
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy † 1	0/414 (0.00%)	1/419 (0.24%)
Abortion spontaneous † 1	1/414 (0.24%)	2/419 (0.48%)
Psychiatric disorders
Suicidal ideation † 1	2/414 (0.48%)	2/419 (0.48%)
Suicide attempt † 1	3/414 (0.72%)	2/419 (0.48%)
Depression † 1	1/414 (0.24%)	3/419 (0.72%)
Homicidal ideation † 1	1/414 (0.24%)	1/419 (0.24%)
Alcohol abuse † 1	0/414 (0.00%)	1/419 (0.24%)
Bipolar I disorder † 1	0/414 (0.00%)	1/419 (0.24%)
Hallucination, visual † 1	0/414 (0.00%)	1/419 (0.24%)
Mania † 1	0/414 (0.00%)	1/419 (0.24%)
Paranoia † 1	0/414 (0.00%)	1/419 (0.24%)
Suicidal behaviour † 1	0/414 (0.00%)	1/419 (0.24%)
Anxiety † 1	0/414 (0.00%)	1/419 (0.24%)
Drug abuse † 1	1/414 (0.24%)	0/419 (0.00%)
Mental disorder † 1	0/414 (0.00%)	1/419 (0.24%)
Nervousness † 1	0/414 (0.00%)	1/419 (0.24%)
Personality disorder † 1	0/414 (0.00%)	1/419 (0.24%)
Schizophrenia, paranoid type † 1	1/414 (0.24%)	0/419 (0.00%)
Shared psychotic disorder † 1	1/414 (0.24%)	0/419 (0.00%)
Renal and urinary disorders
Renal cyst † 1	1/414 (0.24%)	0/419 (0.00%)
Renal failure † 1	0/414 (0.00%)	1/419 (0.24%)
Renal failure chronic † 1	0/414 (0.00%)	1/419 (0.24%)
Renal failure acute † 1	1/414 (0.24%)	1/419 (0.24%)
Nephrolithiasis † 1	1/414 (0.24%)	0/419 (0.00%)
Reproductive system and breast disorders
Bartholin's cyst † 1	1/414 (0.24%)	0/419 (0.00%)
Priapism † 1	1/414 (0.24%)	0/419 (0.00%)
Respiratory, thoracic and mediastinal disorders
Respiratory distress † 1	0/414 (0.00%)	2/419 (0.48%)
Pleural effusion † 1	1/414 (0.24%)	0/419 (0.00%)
Pneumonia aspiration † 1	1/414 (0.24%)	1/419 (0.24%)
Respiratory failure † 1	0/414 (0.00%)	1/419 (0.24%)
Tonsillar disorder † 1	1/414 (0.24%)	0/419 (0.00%)
Pneumothorax † 1	1/414 (0.24%)	0/419 (0.00%)
Pneumothorax spontaneous † 1	1/414 (0.24%)	0/419 (0.00%)
Sleep apnoea syndrome † 1	1/414 (0.24%)	0/419 (0.00%)
Skin and subcutaneous tissue disorders
Angioedema † 1	1/414 (0.24%)	0/419 (0.00%)
Vascular disorders
Deep vein thrombosis † 1	0/414 (0.00%)	1/419 (0.24%)
Hypertensive crisis † 1	1/414 (0.24%)	0/419 (0.00%)
Thrombosis † 1	1/414 (0.24%)	0/419 (0.00%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily	EFV/TDF/FTC 600/200/300 mg Once Daily
	Affected / at Risk (%)	Affected / at Risk (%)
Total	332/414 (80.19%)	358/419 (85.44%)
Gastrointestinal disorders
Diarrhoea † 1	94/414 (22.71%)	89/419 (21.24%)
Nausea † 1	70/414 (16.91%)	63/419 (15.04%)
Vomiting † 1	28/414 (6.76%)	27/419 (6.44%)
General disorders
Fatigue † 1	67/414 (16.18%)	56/419 (13.37%)
Pyrexia † 1	27/414 (6.52%)	30/419 (7.16%)
Infections and infestations
Nasopharyngitis † 1	86/414 (20.77%)	81/419 (19.33%)
Upper respiratory tract infection † 1	69/414 (16.67%)	58/419 (13.84%)
Bronchitis † 1	33/414 (7.97%)	33/419 (7.88%)
Syphilis † 1	26/414 (6.28%)	31/419 (7.40%)
Sinusitis † 1	29/414 (7.00%)	18/419 (4.30%)
Influenza † 1	31/414 (7.49%)	14/419 (3.34%)
Gastroenteritis † 1	26/414 (6.28%)	18/419 (4.30%)
Musculoskeletal and connective tissue disorders
Back pain † 1	37/414 (8.94%)	25/419 (5.97%)
Arthralgia † 1	28/414 (6.76%)	24/419 (5.73%)
Pain in extremity † 1	23/414 (5.56%)	14/419 (3.34%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts † 1	23/414 (5.56%)	17/419 (4.06%)
Nervous system disorders
Dizziness † 1	43/414 (10.39%)	154/419 (36.75%)
Headache † 1	67/414 (16.18%)	64/419 (15.27%)
Somnolence † 1	10/414 (2.42%)	24/419 (5.73%)
Psychiatric disorders
Insomnia † 1	74/414 (17.87%)	52/419 (12.41%)
Abnormal dreams † 1	32/414 (7.73%)	74/419 (17.66%)
Depression † 1	34/414 (8.21%)	38/419 (9.07%)
Anxiety † 1	33/414 (7.97%)	35/419 (8.35%)
Nightmare † 1	11/414 (2.66%)	21/419 (5.01%)
Respiratory, thoracic and mediastinal disorders
Cough † 1	39/414 (9.42%)	40/419 (9.55%)
Oropharyngeal pain † 1	32/414 (7.73%)	19/419 (4.53%)
Skin and subcutaneous tissue disorders
Rash † 1	22/414 (5.31%)	63/419 (15.04%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: GSK Response Center
• Organization: GlaxoSmithKline
• Phone: 866-435-7343

Publications:

Brinson C, Walmsley S, Arasteh K, et al. Dolutegravir treatment response and safety by key subgroups in treatment naive HIV-infected individuals. Published at: Conference on Retroviruses and Opportunistic Infections - 20th Annual; March 3-6, 2013; Atlanta, GA.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Walmsley S, Baumgarten A, Berenguer J, Felizarta F, Florence E, Khuong-Josses MA, Kilby JM, Lutz T, Podzamczer D, Portilla J, Roth N, Wong D, Granier C, Wynne B, Pappa K. Brief Report: Dolutegravir Plus Abacavir/Lamivudine for the Treatment of HIV-1 Infection in Antiretroviral Therapy-Naive Patients: Week 96 and Week 144 Results From the SINGLE Randomized Clinical Trial. J Acquir Immune Defic Syndr. 2015 Dec 15;70(5):515-9. doi: 10.1097/QAI.0000000000000790. Erratum in: J Acquir Immune Defic Syndr. 2016 Jan 1;71(1):e33.

Walmsley SL, Antela A, Clumeck N, Duiculescu D, Eberhard A, Gutiérrez F, Hocqueloux L, Maggiolo F, Sandkovsky U, Granier C, Pappa K, Wynne B, Min S, Nichols G; SINGLE Investigators. Dolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infection. N Engl J Med. 2013 Nov 7;369(19):1807-18. doi: 10.1056/NEJMoa1215541.

• Responsible Party: ViiV Healthcare
• ClinicalTrials.gov Identifier: NCT01263015
• Other Study ID Numbers: 114467
• First Submitted: December 16, 2010
• First Posted: December 20, 2010
• Results First Submitted: August 15, 2013
• Results First Posted: July 2, 2014
• Last Update Posted: April 4, 2018