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

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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:
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
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
Hide 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
Arm/Group Title DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily EFV/TDF/FTC 600/200/300 mg Once Daily Total
Hide 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
Hide 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
1.Primary Outcome
Title Proportion of Subjects Responding Based on Plasma HIV-1 RNA <50 c/mL at Week 48
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Show Statistical Analysis 1 Hide 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)
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Show Statistical Analysis 1 Hide 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.
Show Statistical Analysis 2 Hide 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
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Hide 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
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Hide 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
Hide 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)
Show Statistical Analysis 1 Hide 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Hide 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
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Hide 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
Hide 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)
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
Hide 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   --/--   --/-- 
Show Serious Adverse Events Hide 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
Show Other (Not Including Serious) Adverse Events Hide 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
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.
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01263015     History of Changes
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