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An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir (DTG) Plus Lamivudine (3TC) With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Subjects (Gemini 2)

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ClinicalTrials.gov Identifier: NCT02831764
Recruitment Status : Active, not recruiting
First Posted : July 13, 2016
Results First Posted : April 22, 2019
Last Update Posted : August 9, 2019
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Infection, Human Immunodeficiency Virus
HIV Infections
Interventions Drug: Dolutegravir (DTG)
Drug: Lamivudine (3TC)
Drug: Tenofovir disoproxil fumarate/Emtricitabine (TDF/FTC FDC)
Enrollment 722
Recruitment Details This study is a Phase 3, randomized, double-blind, parallel group, non-inferiority study. A total of 104 investigational centers in 18 countries randomized one or more participants in this multicenter study. The results presented are based on the primary analysis at Week 48.
Pre-assignment Details Total of 722 participants were enrolled and randomized; however only 719 participants (3 participants were never dosed following randomization as they withdrew consent to participate in study) were dosed in to the study to receive either dolutegravir plus lamivudine (DTG+3TC) or dolutegravir plus tenofovir/emtricitabine (DTG+TDF/FTC).
Arm/Group Title DTG + 3TC DTG + TDF/FTC
Hide Arm/Group Description Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks. Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 48 weeks.
Period Title: Overall Study
Started 360 359
Completed 0 0
Not Completed 360 359
Reason Not Completed
Protocol specific withdrawal criteria             0             2
Withdrawal by Subject             7             6
Physician Decision             2             2
Lost to Follow-up             6             5
Adverse Event             8             5
Lack of Efficacy             2             2
Protocol Violation             5             2
Ongoing at the time of the analysis             330             335
Arm/Group Title DTG + 3TC DTG + TDF/FTC Total
Hide Arm/Group Description Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks. Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily for 48 weeks. Total of all reporting groups
Overall Number of Baseline Participants 360 359 719
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 360 participants 359 participants 719 participants
34.6  (10.72) 34.4  (10.35) 34.5  (10.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 360 participants 359 participants 719 participants
Female
54
  15.0%
46
  12.8%
100
  13.9%
Male
306
  85.0%
313
  87.2%
619
  86.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 360 participants 359 participants 719 participants
American (Am) Indian or Alaska (Al.) native
21
   5.8%
24
   6.7%
45
   6.3%
Asian-Central/South Asian heritage (H.)
0
   0.0%
3
   0.8%
3
   0.4%
Asian - East Asian H.
28
   7.8%
26
   7.2%
54
   7.5%
Asian - South East Asian H.
6
   1.7%
1
   0.3%
7
   1.0%
Black or African Am
55
  15.3%
40
  11.1%
95
  13.2%
Native Hawaiian or other Pacific Islander
0
   0.0%
5
   1.4%
5
   0.7%
White (Wt)-Arabic/North African H.
3
   0.8%
3
   0.8%
6
   0.8%
Wt-Wt/Caucasian (Ca.)/European (Eu.) H.
234
  65.0%
246
  68.5%
480
  66.8%
Am Indian or Al. native and Wt
12
   3.3%
10
   2.8%
22
   3.1%
Black or African Am and Wt
1
   0.3%
1
   0.3%
2
   0.3%
1.Primary Outcome
Title Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL (c/mL) at Week 48
Hide Description Percentage of participants with HIV-1 RNA<50 c/mL was obtained using Food and Drug Administration (FDA) Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest. This endpoint was analyzed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights. Intent-To-Treat Exposed (ITT-E) Population was used which comprised of all randomized participants who received at least one dose of study treatment.
Time Frame Week 48
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Hide Analysis Population Description
ITT-E Population
Arm/Group Title DTG + 3TC DTG + TDF/FTC
Hide Arm/Group Description:
Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks.
Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily for 48 weeks.
Overall Number of Participants Analyzed 360 359
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
93
(90.4 to 95.7)
94
(91.4 to 96.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Treatment with DTG+ 3TC was to be declared non-inferior to treatment with DTG+TDF/FTC if the lower end of a two-sided 95% confidence interval for the difference between the two groups in response rates at Week 48 was greater than -10%.
Method of Estimation Estimation Parameter Adjusted difference in proportion
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-4.3 to 2.9
Estimation Comments Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (<= vs. >100,000 copies per milliliter) and CD4+ cell count (<= vs. >200 cells per cubic millimeter [cells/mm^3]).
2.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 24
Hide Description Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with CMH weights.
Time Frame Week 24
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Hide Analysis Population Description
ITT-E Population
Arm/Group Title DTG + 3TC DTG + TDF/FTC
Hide Arm/Group Description:
Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks.
Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily for 48 weeks.
Overall Number of Participants Analyzed 360 359
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
94
(91.4 to 96.4)
94
(91.4 to 96.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Treatment with DTG+ 3TC was to be declared non-inferior to treatment with DTG+TDF/FTC if the lower end of a two-sided 95% confidence interval for the difference between the two groups in response rates at Week 48 was greater than -10%.
Method of Estimation Estimation Parameter Adjusted difference in proportion
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-3.4 to 3.6
Estimation Comments Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (<= vs. >100,000 c/mL) and CD4+ cell count (<= vs. >200 cells/mm^3).
3.Secondary Outcome
Title Time to Viral Suppression (HIV-1 RNA <50 c/mL)
Hide Description Time of viral suppression is defined as the first viral load value <50 c/mL. Nonparametric Kaplan-Meier method was performed. Participants who withdrew for any reason without being suppressed were censored at date of withdrawal. Participants who have not been withdrawn and have not had viral suppression at time of the analysis were censored at last viral load date. Confidence Interval (CI) was estimated using the Brookmeyer-Crowley method. Median along with first Quartile and third Quartile have been presented.
Time Frame Up to Week 48
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Hide Analysis Population Description
ITT-E Population
Arm/Group Title DTG + 3TC DTG + TDF/FTC
Hide Arm/Group Description:
Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks.
Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily for 48 weeks.
Overall Number of Participants Analyzed 360 359
Median (Inter-Quartile Range)
Unit of Measure: Days
29.0
(29.0 to 55.0)
29.0
(29.0 to 57.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.825
Comments The generalised Wilcoxon procedure was used to estimate a p-value for detecting a difference in cumulative incidence curves between treatment groups.
Method Generalised Wilcoxon procedure
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.88 to 1.18
Estimation Comments Hazard ratios were estimated using the Cox proportional hazard regression model.
4.Secondary Outcome
Title CD4+ Cell Counts at Weeks 24 and 48
Hide Description CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry.
Time Frame Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
Arm/Group Title DTG + 3TC DTG + TDF/FTC
Hide Arm/Group Description:
Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks.
Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily for 48 weeks.
Overall Number of Participants Analyzed 360 359
Mean (Standard Deviation)
Unit of Measure: Cells/mm^3
Week 24, n=349,345 Number Analyzed 349 participants 345 participants
650.4  (257.02) 633.0  (287.37)
Week 48, n=337,340 Number Analyzed 337 participants 340 participants
688.1  (266.39) 689.8  (308.49)
5.Secondary Outcome
Title Changes From Baseline in CD4+ Cell Counts at Week 24 and 48
Hide Description CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted least mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor.
Time Frame Baseline and Weeks 24, 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
Arm/Group Title DTG + 3TC DTG + TDF/FTC
Hide Arm/Group Description:
Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks.
Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily for 48 weeks.
Overall Number of Participants Analyzed 360 359
Least Squares Mean (Standard Error)
Unit of Measure: Cells/mm^3
Week 24, n=349, 345 Number Analyzed 349 participants 345 participants
188.8  (8.77) 163.2  (9.08)
Week 48, n=337, 340 Number Analyzed 337 participants 340 participants
225.7  (8.94) 217.2  (9.93)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.043
Comments [Not Specified]
Method Mixed Model Repeated Measures (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 25.6
Confidence Interval (2-Sided) 95%
0.8 to 50.4
Estimation Comments Week 24. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.523
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 8.5
Confidence Interval (2-Sided) 95%
-17.7 to 34.8
Estimation Comments Week 48. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.
6.Secondary Outcome
Title Number of Participants With HIV-1 Disease Progression
Hide Description HIV-associated conditions were recorded during the study and was assessed according to the 2014 Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection in Adults. Disease progressions summarize participants who had HIV infection stage 3 associated conditions or death. Indicators of clinical disease progression were defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrolment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrolment to Death.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title DTG + 3TC DTG + TDF/FTC
Hide Arm/Group Description:
Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks.
Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily for 48 weeks.
Overall Number of Participants Analyzed 360 359
Measure Type: Count of Participants
Unit of Measure: Participants
No disease progression
356
  98.9%
358
  99.7%
From CDC Stage 1 to CDC Stage 3 Event
0
   0.0%
0
   0.0%
From CDC Stage 2 to CDC Stage 3 Event
1
   0.3%
1
   0.3%
From CDC Stage 3 to New CDC Stage 3 Event
1
   0.3%
0
   0.0%
From CDC Stage 1, 2 or 3 to Death
2
   0.6%
0
   0.0%
7.Secondary Outcome
Title Number of Participants With Treatment-emergent Genotypic Resistance
Hide Description Number of participants, who meet confirmed virologic withdrawal (CVW) criteria, with treatment emergent genotypic resistance to Integrase strand transfer inhibitor (INSTI) and/or Nucleoside reverse transcriptase inhibitor (NRTI) was summarized. The Viral Genotypic Population comprised of all participants in the ITT-E population who have available on-treatment genotypic resistance data.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Viral Genotypic Population
Arm/Group Title DTG + 3TC DTG + TDF/FTC
Hide Arm/Group Description:
Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks.
Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily for 48 weeks.
Overall Number of Participants Analyzed 2 2
Measure Type: Count of Participants
Unit of Measure: Participants
INSTI Mutations
0
   0.0%
0
   0.0%
Major mutations of the NRTI
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Number of Participants With Treatment-emergent Phenotypic Resistance
Hide Description Number of participants, who meet CVW criteria, with treatment emergent phenotypic resistance to INSTI and/or NRTI were summarized. Assessment of antiviral activity of anti-retroviral therapy (ART) using phenotypic test results were interpreted through a proprietary algorithm (from Monogram Biosciences) and provides the overall susceptibility of the drugs (Abacavir [ABC], elvitegravir [EGV], raltegravir [RAL], zidovudine [AZT], stavudine [D4T], didanosine [DDI]), emtricitabine [FTC], tenofovir disiproxil fumarate [TDF]). Partially sensitive and resistant cells were considered resistant in this analysis. Number of participants with phenotype at time of CVW by phenotypic cut-off at or prior to Week 48 have been presented. The Viral Phenotypic Population comprised of all participants in the ITT-E population who have available on-treatment phenotypic resistance data. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
Time Frame Up to Week 48
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Hide Analysis Population Description
Viral Phenotypic Population
Arm/Group Title DTG + 3TC DTG + TDF/FTC
Hide Arm/Group Description:
Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks.
Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily for 48 weeks.
Overall Number of Participants Analyzed 2 2
Measure Type: Count of Participants
Unit of Measure: Participants
INSTI, DTG, Sensitive, n=2,1 Number Analyzed 2 participants 1 participants
2
 100.0%
1
 100.0%
INSTI, DTG, Resistant, n=2,1 Number Analyzed 2 participants 1 participants
0
   0.0%
0
   0.0%
INSTI, EGV, Sensitive, n=2,1 Number Analyzed 2 participants 1 participants
2
 100.0%
1
 100.0%
INSTI, EGV, Resistant, n=2,1 Number Analyzed 2 participants 1 participants
0
   0.0%
0
   0.0%
INSTI, RAL, Sensitive, n=2,1 Number Analyzed 2 participants 1 participants
2
 100.0%
1
 100.0%
INSTI, RAL, Resistant, n=2,1 Number Analyzed 2 participants 1 participants
0
   0.0%
0
   0.0%
NRTI, 3TC, Sensitive, n=2,2 Number Analyzed 2 participants 2 participants
2
 100.0%
2
 100.0%
NRTI, 3TC, Resistant, n=2,2 Number Analyzed 2 participants 2 participants
0
   0.0%
0
   0.0%
NRTI, ABC, Sensitive, n=2,2 Number Analyzed 2 participants 2 participants
2
 100.0%
2
 100.0%
NRTI, ABC, Resistant, n=2,2 Number Analyzed 2 participants 2 participants
0
   0.0%
0
   0.0%
NRTI, AZT, Sensitive, n=2,2 Number Analyzed 2 participants 2 participants
2
 100.0%
2
 100.0%
NRTI, AZT, Resistant, n=2,2 Number Analyzed 2 participants 2 participants
0
   0.0%
0
   0.0%
NRTI, D4T, Sensitive, n=2,2 Number Analyzed 2 participants 2 participants
2
 100.0%
2
 100.0%
NRTI, D4T, Resistant, n=2,2 Number Analyzed 2 participants 2 participants
0
   0.0%
0
   0.0%
NRTI, DDI, Sensitive, n=2,2 Number Analyzed 2 participants 2 participants
2
 100.0%
2
 100.0%
NRTI, DDI, Resistant, n=2,2 Number Analyzed 2 participants 2 participants
0
   0.0%
0
   0.0%
NRTI, FTC, Sensitive, n=2,2 Number Analyzed 2 participants 2 participants
2
 100.0%
2
 100.0%
NRTI, FTC, Resistant, n=2,2 Number Analyzed 2 participants 2 participants
0
   0.0%
0
   0.0%
NRTI, TDF, Sensitive, n=2,2 Number Analyzed 2 participants 2 participants
2
 100.0%
2
 100.0%
NRTI, TDF, Resistant, n=2,2 Number Analyzed 2 participants 2 participants
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Number of Participants With Any Adverse Event (AE) and Serious AE (SAE)
Hide Description An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. Safety Population was used which comprised of all participants who received at least one dose of study treatment. Analyses presented herein used a data cut-off date of 22 May 2018 (for Week 48 database freeze), i.e. may include data collected after a participant’s Week 48 visit.
Time Frame Up to Week 48
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Hide Analysis Population Description
Safety Population
Arm/Group Title DTG + 3TC DTG + TDF/FTC
Hide Arm/Group Description:
Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks.
Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily for 48 weeks.
Overall Number of Participants Analyzed 360 359
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE
267
  74.2%
284
  79.1%
Any SAE
29
   8.1%
33
   9.2%
10.Secondary Outcome
Title Number of Participants With AEs by Maximum Severity Grades
Hide Description An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented. Analyses presented herein used a data cut-off date of 22 May 2018 (for Week 48 database freeze), i.e. may include data collected after a participant’s Week 48 visit.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG + 3TC DTG + TDF/FTC
Hide Arm/Group Description:
Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks.
Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily for 48 weeks.
Overall Number of Participants Analyzed 360 359
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1 AEs
79
  21.9%
93
  25.9%
Grade 2 AEs
161
  44.7%
159
  44.3%
Grade 3 AEs
19
   5.3%
29
   8.1%
Grade 4 AEs
6
   1.7%
3
   0.8%
Grade 5 AEs
2
   0.6%
0
   0.0%
11.Secondary Outcome
Title Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade
Hide Description An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were evaluated by the investigator and graded according to the DAIDS toxicity scales from Grade 1 to 5. (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with drug related AEs and drug related AEs by by maximum grade have been presented. Analyses presented herein used a data cut-off date of 22 May 2018 (for Week 48 database freeze), i.e. may include data collected after a participant’s Week 48 visit.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG + 3TC DTG + TDF/FTC
Hide Arm/Group Description:
Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks.
Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily for 48 weeks.
Overall Number of Participants Analyzed 360 359
Measure Type: Count of Participants
Unit of Measure: Participants
Any drug related AE
55
  15.3%
75
  20.9%
Drug related AEs with maximum toxicity Grade 1
34
   9.4%
53
  14.8%
Drug related AEs with maximum toxicity Grade 2
17
   4.7%
17
   4.7%
Drug related AEs with maximum toxicity Grade 3
3
   0.8%
4
   1.1%
Drug related AEs with maximum toxicity Grade 4
1
   0.3%
1
   0.3%
Drug related AEs with maximum toxicity Grade 5
0
   0.0%
0
   0.0%
12.Secondary Outcome
Title Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities
Hide Description Blood samples were collected up to Week 48 for assessment of platelet count, neutrophils, hemoglobin, and Leukocytes. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Only those participants with maximum post-Baseline emergent hematology toxicities in any of the listed hematology parameters have been presented.
Time Frame Up to Week 48
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Safety Population
Arm/Group Title DTG + 3TC DTG + TDF/FTC
Hide Arm/Group Description:
Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks.
Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily for 48 weeks.
Overall Number of Participants Analyzed 360 359
Measure Type: Count of Participants
Unit of Measure: Participants
Hemoglobin, Grades 1 to 4
8
   2.2%
7
   1.9%
Hemoglobin, Grades 2 to 4
5
   1.4%
4
   1.1%
Hemoglobin, Grades 3 to 4
2
   0.6%
1
   0.3%
Hemoglobin, Grade 1
3
   0.8%
3
   0.8%
Hemoglobin, Grade 2
3
   0.8%
3
   0.8%
Hemoglobin, Grade 3
1
   0.3%
1
   0.3%
Hemoglobin, Grade 4
1
   0.3%
0
   0.0%
Leukocytes, Grades 1 to 4
4
   1.1%
3
   0.8%
Leukocytes, Grades 2 to 4
1
   0.3%
0
   0.0%
Leukocytes, Grades 3 to 4
0
   0.0%
0
   0.0%
Leukocytes, Grade 1
3
   0.8%
3
   0.8%
Leukocytes, Grade 2
1
   0.3%
0
   0.0%
Leukocytes, Grade 3
0
   0.0%
0
   0.0%
Leukocytes, Grade 4
0
   0.0%
0
   0.0%
Neutrophils, Grades 1 to 4
14
   3.9%
6
   1.7%
Neutrophils, Grades 2 to 4
4
   1.1%
2
   0.6%
Neutrophils, Grades 3 to 4
1
   0.3%
1
   0.3%
Neutrophils, Grade 1
10
   2.8%
4
   1.1%
Neutrophils, Grade 2
3
   0.8%
1
   0.3%
Neutrophils, Grade 3
1
   0.3%
1
   0.3%
Neutrophils, Grade 4
0
   0.0%
0
   0.0%
Platelets, Grades 1 to 4
11
   3.1%
9
   2.5%
Platelets, Grades 2 to 4
5
   1.4%
5
   1.4%
Platelets, Grades 3 to 4
0
   0.0%
0
   0.0%
Platelets, Grade 1
6
   1.7%
4
   1.1%
Platelets, Grade 2
5
   1.4%
5
   1.4%
Platelets, Grade 3
0
   0.0%
0
   0.0%
Platelets, Grade 4
0
   0.0%
0
   0.0%
13.Secondary Outcome
Title Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities
Hide Description Blood samples were collected up to Week 48 for assessment of Alanine Aminotransferase (ALT), Aspartate aminotransferase (AST), Albumin, Alkaline Phosphatase (ALP), Bilirubin, Carbon dioxide (CO2), Cholesterol, Creatine kinase (CPK), Creatinine, Direct Bilirubin, Glomerular filtration rate (GFR), Hypercalcemia, Hyperglycemia, Hyperkalemia, Hypernatremia, Hypocalcemia, Hypoglycemia, Hypokalemia and Hyponatremia, Low density lipid (LDL) Cholesterol, Lactate Dehydrogenase, Lipase and Phosphate. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Only those participants with maximum post-Baseline emergent chemistry toxicities in any of the chemistry parameters have been presented.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG + 3TC DTG + TDF/FTC
Hide Arm/Group Description:
Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks.
Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily for 48 weeks.
Overall Number of Participants Analyzed 360 359
Measure Type: Count of Participants
Unit of Measure: Participants
ALT, Grades 1 to 4
43
  11.9%
51
  14.2%
ALT, Grades 2 to 4
17
   4.7%
22
   6.1%
ALT, Grades 3 to 4
9
   2.5%
10
   2.8%
ALT, Grade 1
26
   7.2%
29
   8.1%
ALT, Grade 2
8
   2.2%
12
   3.3%
ALT, Grade 3
4
   1.1%
4
   1.1%
ALT, Grade 4
5
   1.4%
6
   1.7%
Albumin, Grades 1 to 4
0
   0.0%
1
   0.3%
Albumin, Grades 2 to 4
0
   0.0%
1
   0.3%
Albumin, Grades 3 to 4
0
   0.0%
1
   0.3%
Albumin, Grade 1
0
   0.0%
0
   0.0%
Albumin, Grade 2
0
   0.0%
0
   0.0%
Albumin, Grade 3
0
   0.0%
1
   0.3%
Albumin, Grade 4
0
   0.0%
0
   0.0%
ALP, Grades 1 to 4
6
   1.7%
14
   3.9%
ALP, Grades 2 to 4
2
   0.6%
3
   0.8%
ALP, Grades 3 to 4
0
   0.0%
1
   0.3%
ALP, Grade 1
4
   1.1%
11
   3.1%
ALP, Grade 2
2
   0.6%
2
   0.6%
ALP, Grade 3
0
   0.0%
1
   0.3%
ALP, Grade 4
0
   0.0%
0
   0.0%
AST, Grades 1 to 4
42
  11.7%
56
  15.6%
AST, Grades 2 to 4
17
   4.7%
23
   6.4%
AST, Grades 3 to 4
7
   1.9%
12
   3.3%
AST, Grade 1
25
   6.9%
33
   9.2%
AST, Grade 2
10
   2.8%
11
   3.1%
AST, Grade 3
3
   0.8%
9
   2.5%
AST, Grade 4
4
   1.1%
3
   0.8%
Bilirubin, Grades 1 to 4
33
   9.2%
38
  10.6%
Bilirubin, Grades 2 to 4
8
   2.2%
11
   3.1%
Bilirubin, Grades 3 to 4
3
   0.8%
3
   0.8%
Bilirubin, Grade 1
25
   6.9%
27
   7.5%
Bilirubin, Grade 2
5
   1.4%
8
   2.2%
Bilirubin, Grade 3
0
   0.0%
2
   0.6%
Bilirubin, Grade 4
3
   0.8%
1
   0.3%
CO2, Grades 1 to 4
71
  19.7%
87
  24.2%
CO2, Grades 2 to 4
6
   1.7%
2
   0.6%
CO2, Grades 3 to 4
0
   0.0%
0
   0.0%
CO2, Grade 1
65
  18.1%
85
  23.7%
CO2, Grade 2
6
   1.7%
2
   0.6%
CO2, Grade 3
0
   0.0%
0
   0.0%
CO2, Grade 4
0
   0.0%
0
   0.0%
Cholesterol, Grades 1 to 4
70
  19.4%
26
   7.2%
Cholesterol, Grades 2 to 4
11
   3.1%
5
   1.4%
Cholesterol, Grades 3 to 4
0
   0.0%
0
   0.0%
Cholesterol, Grade 1
59
  16.4%
21
   5.8%
Cholesterol, Grade 2
11
   3.1%
5
   1.4%
Cholesterol, Grade 3
0
   0.0%
0
   0.0%
Cholesterol, Grade 4
0
   0.0%
0
   0.0%
CK, Grades 1 to 4
61
  16.9%
48
  13.4%
CK, Grades 2 to 4
34
   9.4%
28
   7.8%
CK, Grades 3 to 4
19
   5.3%
17
   4.7%
CK, Grade 1
27
   7.5%
20
   5.6%
CK, Grade 2
15
   4.2%
11
   3.1%
CK, Grade 3
9
   2.5%
6
   1.7%
CK, Grade 4
10
   2.8%
11
   3.1%
Creatinine, Grades 1 to 4
14
   3.9%
19
   5.3%
Creatinine, Grades 2 to 4
3
   0.8%
2
   0.6%
Creatinine, Grades 3 to 4
0
   0.0%
1
   0.3%
Creatinine, Grade 1
11
   3.1%
17
   4.7%
Creatinine, Grade 2
3
   0.8%
1
   0.3%
Creatinine, Grade 3
0
   0.0%
1
   0.3%
Creatinine, Grade 4
0
   0.0%
0
   0.0%
Direct Bilirubin, Grades 1 to 4
7
   1.9%
7
   1.9%
Direct Bilirubin, Grades 2 to 4
7
   1.9%
7
   1.9%
Direct Bilirubin, Grades 3 to 4
7
   1.9%
7
   1.9%
Direct Bilirubin, Grade 1
0
   0.0%
0
   0.0%
Direct Bilirubin, Grade 2
0
   0.0%
0
   0.0%
Direct Bilirubin, Grade 3
7
   1.9%
7
   1.9%
Direct Bilirubin, Grade 4
0
   0.0%
0
   0.0%
GFR, Grades 1 to 4
154
  42.8%
190
  52.9%
GFR, Grades 2 to 4
154
  42.8%
190
  52.9%
GFR, Grades 3 to 4
13
   3.6%
18
   5.0%
GFR, Grade 1
0
   0.0%
0
   0.0%
GFR, Grade 2
141
  39.2%
172
  47.9%
GFR, Grade 3
13
   3.6%
17
   4.7%
GFR, Grade 4
0
   0.0%
1
   0.3%
Hypercalcaemia, Grades 1 to 4
3
   0.8%
5
   1.4%
Hypercalcaemia, Grades 2 to 4
0
   0.0%
1
   0.3%
Hypercalcaemia, Grades 3 to 4
0
   0.0%
1
   0.3%
Hypercalcemia, Grade 1
3
   0.8%
4
   1.1%
Hypercalcaemia, Grade 2
0
   0.0%
0
   0.0%
Hypercalcaemia, Grade 3
0
   0.0%
0
   0.0%
Hypercalcaemia, Grade 4
0
   0.0%
1
   0.3%
Hyperglycaemia, Grades 1 to 4
74
  20.6%
57
  15.9%
Hyperglycaemia, Grades 2 to 4
30
   8.3%
21
   5.8%
Hyperglycaemia, Grades 3 to 4
2
   0.6%
3
   0.8%
Hyperglycaemia, Grade 1
44
  12.2%
36
  10.0%
Hyperglycaemia, Grade 2
28
   7.8%
18
   5.0%
Hyperglycaemia, Grade 3
2
   0.6%
2
   0.6%
Hyperglycaemia, Grade 4
0
   0.0%
1
   0.3%
Hyperkalemia, Grades 1 to 4
4
   1.1%
4
   1.1%
Hyperkalemia, Grades 2 to 4
1
   0.3%
0
   0.0%
Hyperkalemia, Grades 3 to 4
0
   0.0%
0
   0.0%
Hyperkalemia, Grade 1
3
   0.8%
4
   1.1%
Hyperkalemia, Grade 2
1
   0.3%
0
   0.0%
Hyperkalemia, Grade 3
0
   0.0%
0
   0.0%
Hyperkalemia, Grade 4
0
   0.0%
0
   0.0%
Hypernatremia, Grades 1 to 4
1
   0.3%
5
   1.4%
Hypernatremia, Grades 2 to 4
0
   0.0%
0
   0.0%
Hypernatremia, Grades 3 to 4
0
   0.0%
0
   0.0%
Hypernatremia, Grade 1
1
   0.3%
5
   1.4%
Hypernatremia, Grade 2
0
   0.0%
0
   0.0%
Hypernatremia, Grade 3
0
   0.0%
0
   0.0%
Hypernatremia, Grade 4
0
   0.0%
0
   0.0%
Hypocalcaemia, Grades 1 to 4
7
   1.9%
10
   2.8%
Hypocalcaemia, Grades 2 to 4
1
   0.3%
5
   1.4%
Hypocalcaemia, Grades 3 to 4
0
   0.0%
1
   0.3%
Hypocalcaemia, Grade 1
6
   1.7%
5
   1.4%
Hypocalcaemia, Grade 2
1
   0.3%
4
   1.1%
Hypocalcaemia, Grade 3
0
   0.0%
1
   0.3%
Hypocalcaemia, Grade 4
0
   0.0%
0
   0.0%
Hypoglycaemia, Grades 1 to 4
13
   3.6%
13
   3.6%
Hypoglycaemia, Grades 2 to 4
4
   1.1%
4
   1.1%
Hypoglycaemia, Grades 3 to 4
3
   0.8%
1
   0.3%
Hypoglycaemia, Grade 1
9
   2.5%
9
   2.5%
Hypoglycaemia, Grade 2
1
   0.3%
3
   0.8%
Hypoglycaemia, Grade 3
2
   0.6%
0
   0.0%
Hypoglycaemia, Grade 4
1
   0.3%
1
   0.3%
Hypokalemia, Grades 1 to 4
3
   0.8%
0
   0.0%
Hypokalemia, Grades 2 to 4
0
   0.0%
0
   0.0%
Hypokalemia, Grades 3 to 4
0
   0.0%
0
   0.0%
Hypokalemia, Grade 1
3
   0.8%
0
   0.0%
Hypokalemia, Grade 2
0
   0.0%
0
   0.0%
Hypokalemia, Grade 3
0
   0.0%
0
   0.0%
Hypokalemia, Grade 4
0
   0.0%
0
   0.0%
Hyponatremia, Grades 1 to 4
14
   3.9%
18
   5.0%
Hyponatremia, Grades 2 to 4
0
   0.0%
2
   0.6%
Hyponatremia, Grades 3 to 4
0
   0.0%
0
   0.0%
Hyponatremia, Grade 1
14
   3.9%
16
   4.5%
Hyponatremia, Grade 2
0
   0.0%
2
   0.6%
Hyponatremia, Grade 3
0
   0.0%
0
   0.0%
Hyponatremia, Grade 4
0
   0.0%
0
   0.0%
LDL Cholesterol, Grades 1 to 4
48
  13.3%
22
   6.1%
LDL Cholesterol, Grades 2 to 4
14
   3.9%
5
   1.4%
LDL Cholesterol, Grades 3 to 4
3
   0.8%
0
   0.0%
LDL Cholesterol, Grade 1
34
   9.4%
17
   4.7%
LDL Cholesterol, Grade 2
11
   3.1%
5
   1.4%
LDL Cholesterol, Grade 3
3
   0.8%
0
   0.0%
LDL Cholesterol, Grade 4
0
   0.0%
0
   0.0%
Lactate Dehydrogenase, Grades 1 to 4
3
   0.8%
2
   0.6%
Lactate Dehydrogenase, Grades 2 to 4
3
   0.8%
0
   0.0%
Lactate Dehydrogenase, Grades 3 to 4
0
   0.0%
0
   0.0%
Lactate Dehydrogenase, Grade 1
0
   0.0%
2
   0.6%
Lactate Dehydrogenase, Grade 2
3
   0.8%
0
   0.0%
Lactate Dehydrogenase, Grade 3
0
   0.0%
0
   0.0%
Lactate Dehydrogenase, Grade 4
0
   0.0%
0
   0.0%
Lipase, Grades 1 to 4
48
  13.3%
60
  16.7%
Lipase, Grades 2 to 4
21
   5.8%
28
   7.8%
Lipase, Grades 3 to 4
2
   0.6%
10
   2.8%
Lipase, Grade 1
27
   7.5%
32
   8.9%
Lipase, Grade 2
19
   5.3%
18
   5.0%
Lipase, Grade 3
0
   0.0%
9
   2.5%
Lipase, Grade 4
2
   0.6%
1
   0.3%
Phosphate, Grades 1 to 4
53
  14.7%
51
  14.2%
Phosphate, Grades 2 to 4
31
   8.6%
33
   9.2%
Phosphate, Grades 3 to 4
2
   0.6%
4
   1.1%
Phosphate, Grade 1
22
   6.1%
18
   5.0%
Phosphate, Grade 2
29
   8.1%
29
   8.1%
Phosphate, Grade 3
2
   0.6%
4
   1.1%
Phosphate, Grade 4
0
   0.0%
0
   0.0%
Triglycerides, Grades 1 to 4
58
  16.1%
52
  14.5%
Triglycerides, Grades 2 to 4
11
   3.1%
7
   1.9%
Triglycerides, Grades 3 to 4
3
   0.8%
1
   0.3%
Triglycerides, Grade 1
47
  13.1%
45
  12.5%
Triglycerides, Grade 2
8
   2.2%
6
   1.7%
Triglycerides, Grade 3
3
   0.8%
1
   0.3%
Triglycerides, Grade 4
0
   0.0%
0
   0.0%
14.Secondary Outcome
Title Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48
Hide Description An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants who discontinued treatment due to AEs have been reported. Analyses presented herein used a data cut-off date of 19 January 2018 and 22 May 2018, respectively, for the Week 24 database freeze and Week 48 database freeze), i.e. may include data collected after a participant’s Week 24 or 48 visit, respectively.
Time Frame Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG + 3TC DTG + TDF/FTC
Hide Arm/Group Description:
Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks.
Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily for 48 weeks.
Overall Number of Participants Analyzed 360 359
Measure Type: Count of Participants
Unit of Measure: Participants
Up to Week 24
6
   1.7%
4
   1.1%
Up to Week 48
8
   2.2%
8
   2.2%
15.Secondary Outcome
Title Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48
Hide Description Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum Cystatin C and Serum RBP. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor.
Time Frame Baseline and at Weeks 24, 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
Arm/Group Title DTG + 3TC DTG + TDF/FTC
Hide Arm/Group Description:
Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks.
Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily for 48 weeks.
Overall Number of Participants Analyzed 360 359
Least Squares Mean (Standard Error)
Unit of Measure: Milligrams per Liter (mg/L)
Serum Cystatin C, Week 24, n=345,345 Number Analyzed 345 participants 345 participants
-0.04  (0.005) 0.00  (0.005)
Serum Cystatin C, Week 48, n=335,336 Number Analyzed 335 participants 336 participants
-0.05  (0.005) -0.04  (0.006)
Serum RBP, Week 24, n=345,343 Number Analyzed 345 participants 343 participants
1.2  (0.42) 1.4  (0.48)
Serum RBP, Week 48, n=334, 334 Number Analyzed 334 participants 334 participants
0.6  (0.45) -0.1  (0.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.05 to -0.02
Estimation Comments Week 24. Serum Cystatin C.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.03 to 0.00
Estimation Comments Week 48. Serum Cystatin C.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.797
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-1.4 to 1.1
Estimation Comments Week 24. Serum RBP
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.258
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-0.5 to 1.9
Estimation Comments Week 48. Serum RBP
16.Secondary Outcome
Title Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48
Hide Description Blood samples were collected to perform evaluation of renal biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI (GFR-cystatin C adjusted) and Serum or Plasma GFR from creatinine adjusted using CKD-EPI. Baseline value is the latest pre-dose Assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor.
Time Frame Baseline and at Weeks 24, 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
Arm/Group Title DTG + 3TC DTG + TDF/FTC
Hide Arm/Group Description:
Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks.
Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily for 48 weeks.
Overall Number of Participants Analyzed 360 359
Mean (Standard Error)
Unit of Measure: Milliliter/minute/1.73 meter^2
GFR Cystatin C adjusted, Week 24, n=345,345 Number Analyzed 345 participants 345 participants
3.8  (0.66) 0.2  (0.65)
GFR Cystatin C adjusted, Week 48, n=335,336 Number Analyzed 335 participants 336 participants
5.4  (0.64) 3.6  (0.64)
GFR creatinine adjusted, Week 24, n=346,344 Number Analyzed 346 participants 344 participants
-12.0  (0.64) -15.4  (0.59)
GFR creatinine adjusted, Week 48, n=335, 337 Number Analyzed 335 participants 337 participants
-12.1  (0.60) -15.4  (0.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.6
Confidence Interval (2-Sided) 95%
1.8 to 5.4
Estimation Comments Week 24. GFR Cystatin C adjusted.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.056
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.7
Confidence Interval (2-Sided) 95%
0.0 to 3.5
Estimation Comments Week 48. GFR Cystatin C adjusted.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.4
Confidence Interval (2-Sided) 95%
1.7 to 5.2
Estimation Comments Week 24. GFR creatinine adjusted.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.3
Confidence Interval (2-Sided) 95%
1.6 to 5.0
Estimation Comments Week 48. GFR creatinine adjusted.
17.Secondary Outcome
Title Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Weeks 24, 48
Hide Description Blood and samples were collected to perform evaluation of renal biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was calculated as value at the inidcated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
Time Frame Baseline and at Weeks 24, 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title DTG + 3TC DTG + TDF/FTC
Hide Arm/Group Description:
Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks.
Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily for 48 weeks.
Overall Number of Participants Analyzed 360 359
Mean (Standard Deviation)
Unit of Measure: Micromoles per Liter (umol/L)
Serum or Plasma Creatinine, Week 24, n=346, 344 Number Analyzed 346 participants 344 participants
10.51  (0.548) 13.53  (0.507)
Serum or Plasma Creatinine, Week 48, n=335, 337 Number Analyzed 335 participants 337 participants
10.32  (0.519) 13.44  (0.540)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.02
Confidence Interval (2-Sided) 95%
-4.49 to -1.55
Estimation Comments Week 24. Serum Plasma Creatinine
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.12
Confidence Interval (2-Sided) 95%
-4.59 to -1.65
Estimation Comments Week 48. Serum Plasma creatinine
18.Secondary Outcome
Title Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48
Hide Description Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers: Urine and Serum B2M, Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine. Baseline value was the latest pre-dose assessment. Change from Baseline was performed on log-transformed data. Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Geometric mean ratio and 95% CI of geometric mean ratio have been presented. Biomarkers were Adjusted for treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, loge transformed Baseline biomarker value, treatment and visit interaction, and loge transformed Baseline biomarker value and visit interaction; with visit as the repeated factor.
Time Frame Baseline and Weeks 24, 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
Arm/Group Title DTG + 3TC DTG + TDF/FTC
Hide Arm/Group Description:
Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks.
Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily for 48 weeks.
Overall Number of Participants Analyzed 360 359
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
Serum B2M, Week 24, n=344,346 Number Analyzed 344 participants 346 participants
0.809
(0.794 to 0.824)
0.882
(0.867 to 0.898)
Serum B2M, Week 48, n=335,336 Number Analyzed 335 participants 336 participants
0.811
(0.796 to 0.827)
0.887
(0.871 to 0.904)
Urine B2M, Week 24, n=124,106 Number Analyzed 124 participants 106 participants
0.844
(0.755 to 0.944)
1.129
(0.974 to 1.309)
Urine B2M, Week 48, n=109, 103 Number Analyzed 109 participants 103 participants
0.917
(0.804 to 1.046)
1.323
(1.066 to 1.642)
Urine Albumin/Creatinine, Week 24, n=259, 251 Number Analyzed 259 participants 251 participants
0.907
(0.844 to 0.976)
1.021
(0.940 to 1.109)
Urine Albumin/Creatinine , Week 48, n=249, 240 Number Analyzed 249 participants 240 participants
0.911
(0.835 to 0.994)
0.971
(0.891 to 1.058)
Urine B2M/Urine Creatinine , Week 24, n=122, 104 Number Analyzed 122 participants 104 participants
0.880
(0.779 to 0.993)
1.126
(0.988 to 1.282)
Urine B2M/Urine Creatinine , Week 48, n=108, 103 Number Analyzed 108 participants 103 participants
0.969
(0.854 to 1.099)
1.307
(1.077 to 1.586)
Urine Phosphate, Week 24, n=343, 340 Number Analyzed 343 participants 340 participants
1.041
(0.955 to 1.134)
1.063
(0.978 to 1.157)
Urine Phosphate, Week 48, n=335, 332 Number Analyzed 335 participants 332 participants
1.121
(1.031 to 1.220)
1.056
(0.974 to 1.144)
Urine Protein/Creatinine, Week 24, n=263,279 Number Analyzed 263 participants 279 participants
0.818
(0.779 to 0.859)
0.991
(0.941 to 1.043)
Urine Protein/Creatinine , Week 48, n=259, 261 Number Analyzed 259 participants 261 participants
0.866
(0.818 to 0.917)
1.007
(0.954 to 1.062)
Urine RBP 4, Week 24, n=340, 338 Number Analyzed 340 participants 338 participants
0.656
(0.591 to 0.729)
0.824
(0.738 to 0.921)
Urine RBP 4, Week 48, n=333, 331 Number Analyzed 333 participants 331 participants
0.740
(0.666 to 0.822)
0.819
(0.730 to 0.919)
Urine RBP 4/Urine Creatinine, Week 24, n=338, 335 Number Analyzed 338 participants 335 participants
0.670
(0.614 to 0.730)
0.811
(0.741 to 0.888)
Urine RBP 4/Urine Creatinine, Week 48, n=331, 328 Number Analyzed 331 participants 328 participants
0.749
(0.689 to 0.814)
0.844
(0.774 to 0.920)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 0.917
Confidence Interval (2-Sided) 95%
0.893 to 0.941
Estimation Comments Week 24. Serum B2M.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 0.914
Confidence Interval (2-Sided) 95%
0.890 to 0.939
Estimation Comments Week 48. Serum B2M.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 0.748
Confidence Interval (2-Sided) 95%
0.621 to 0.901
Estimation Comments Week 24. Urine B2M.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 0.693
Confidence Interval (2-Sided) 95%
0.538 to 0.892
Estimation Comments Week 48. Urine B2M.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 0.889
Confidence Interval (2-Sided) 95%
0.796 to 0.992
Estimation Comments Week 24. Urine Albumin/Creatinine.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.308
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 0.938
Confidence Interval (2-Sided) 95%
0.830 to 1.061
Estimation Comments Week 48. Urine Albumin/Creatinine.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 0.781
Confidence Interval (2-Sided) 95%
0.654 to 0.934
Estimation Comments Week 24. Urine B2M/Urine Creatinine.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 0.742
Confidence Interval (2-Sided) 95%
0.588 to 0.935
Estimation Comments Week 48. Urine B2M/Urine Creatinine.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.728
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 0.979
Confidence Interval (2-Sided) 95%
0.868 to 1.104
Estimation Comments Week 24. Urine Phosphate.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.311
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 1.062
Confidence Interval (2-Sided) 95%
0.945 to 1.194
Estimation Comments Week 48. Urine Phosphate.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 0.826
Confidence Interval (2-Sided) 95%
0.769 to 0.887
Estimation Comments Week 24. Urine Protein/Creatinine.
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 0.860
Confidence Interval (2-Sided) 95%
0.795 to 0.930
Estimation Comments Week 48. Urine Protein/Creatinine.
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 0.796
Confidence Interval (2-Sided) 95%
0.683 to 0.927
Estimation Comments Week 24. Urine RBP 4
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.200
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 0.903
Confidence Interval (2-Sided) 95%
0.773 to 1.056
Estimation Comments Week 48. Urine RBP 4
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 0.826
Confidence Interval (2-Sided) 95%
0.728 to 0.936
Estimation Comments Week 24. Urine RBP/Urine Creatinine
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.052
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 0.888
Confidence Interval (2-Sided) 95%
0.787 to 1.001
Estimation Comments Week 48. Urine RBP/Urine Creatinine
19.Secondary Outcome
Title Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48
Hide Description Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, PINP and CTX-1. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value.
Time Frame Baseline (Day 1) and at Weeks 24, 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
Arm/Group Title DTG + 3TC DTG + TDF/FTC
Hide Arm/Group Description:
Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks.
Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily for 48 weeks.
Overall Number of Participants Analyzed 360 359
Mean (Standard Error)
Unit of Measure: Micrograms per Liter (ug/L)
Bone-ALP, Week 24, n=345, 346 Number Analyzed 345 participants 346 participants
0.72  (0.171) 3.38  (0.244)
Bone-ALP, Week 48, n=334, 337 Number Analyzed 334 participants 337 participants
1.24  (0.198) 4.33  (0.268)
Serum Osteocalcin, Week 24, n=345, 346 Number Analyzed 345 participants 346 participants
2.13  (0.321) 6.80  (0.368)
Serum Osteocalcin, Week 48, n=335, 336 Number Analyzed 335 participants 336 participants
0.40  (0.326) 6.30  (0.384)
PINP, Week 24, n=344, 346 Number Analyzed 344 participants 346 participants
1.7  (0.95) 15.2  (1.12)
PINP, Week 48, n=335, 337 Number Analyzed 335 participants 337 participants
0.4  (0.79) 13.3  (1.06)
CTX-1, Week 24, n=342, 342 Number Analyzed 342 participants 342 participants
0.1541  (0.01247) 0.2812  (0.01406)
CTX-1, Week 48, n=332, 333 Number Analyzed 332 participants 333 participants
0.1345  (0.01496) 0.3388  (0.01983)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.66
Confidence Interval (2-Sided) 95%
-3.25 to -2.08
Estimation Comments Week 24, Bone ALP
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.09
Confidence Interval (2-Sided) 95%
-3.75 to -2.44
Estimation Comments Week 48, Bone ALP
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.67
Confidence Interval (2-Sided) 95%
-5.63 to -3.71
Estimation Comments Week 28, Serum Osteocalcin
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -5.90
Confidence Interval (2-Sided) 95%
-6.89 to -4.91
Estimation Comments Week 48, Serum Osteocalcin
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -13.5
Confidence Interval (2-Sided) 95%
-16.4 to -10.6
Estimation Comments Week 24, Serum PINP
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -12.8
Confidence Interval (2-Sided) 95%
-15.4 to -10.2
Estimation Comments Week 48, Serum PINP
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.1270
Confidence Interval (2-Sided) 95%
-0.1640 to -0.0900
Estimation Comments Week 24, CTX-1
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.2043
Confidence Interval (2-Sided) 95%
-0.2532 to -0.1554
Estimation Comments Week 48, CTX-1
20.Secondary Outcome
Title Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48
Hide Description Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value.
Time Frame Baseline and at Weeks 24, 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
Arm/Group Title DTG + 3TC DTG + TDF/FTC
Hide Arm/Group Description:
Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks.
Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily for 48 weeks.
Overall Number of Participants Analyzed 360 359
Least Squares Mean (Standard Error)
Unit of Measure: Nanomoles per Liter (nmol/L)
Serum Vitamin D, Week 24, n=346, 344 Number Analyzed 346 participants 344 participants
11.2  (1.08) 15.4  (1.33)
Serum Vitamin D, Week 48, n=336, 335 Number Analyzed 336 participants 335 participants
0.3  (0.92) 0.4  (1.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.2
Confidence Interval (2-Sided) 95%
-7.5 to -0.8
Estimation Comments Week 24
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.960
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-2.8 to 2.6
Estimation Comments Week 48
21.Secondary Outcome
Title Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (HDL) Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48
Hide Description Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value is defined as the latest pre-dose assessment (Day 1). Percentage change from Baseline was calculated as 100 multiplied by ([post-dose visit value minus Baseline value] divided by Baseline value).
Time Frame Baseline and at Weeks 24, 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
Arm/Group Title DTG + 3TC DTG + TDF/FTC
Hide Arm/Group Description:
Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks.
Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily for 48 weeks.
Overall Number of Participants Analyzed 360 359
Mean (Standard Deviation)
Unit of Measure: Percentage change
Serum or Plasma Cholesterol, Week 24, n=298, 310 Number Analyzed 298 participants 310 participants
5.0  (16.85) -4.5  (15.44)
Serum or Plasma Cholesterol, Week 48, n=298, 307 Number Analyzed 298 participants 307 participants
9.3  (17.10) -3.3  (14.61)
HDL Cholesterol, Direct, Week 24, n=299, 310 Number Analyzed 299 participants 310 participants
13.9  (25.17) 7.2  (32.22)
HDL Cholesterol, Direct, Week 48, n=299, 307 Number Analyzed 299 participants 307 participants
15.3  (23.75) 4.0  (21.86)
LDL Cholesterol, Week 24, n=298, 309 Number Analyzed 298 participants 309 participants
3.8  (25.85) -7.8  (21.13)
LDL Cholesterol, Week 48, n=297, 307 Number Analyzed 297 participants 307 participants
10.7  (27.54) -4.1  (20.39)
Triglycerides,Week 24, n=299, 310 Number Analyzed 299 participants 310 participants
7.0  (40.45) 0.5  (44.01)
Triglycerides, Week 48, n=299, 307 Number Analyzed 299 participants 307 participants
7.3  (46.92) -0.3  (49.22)
22.Secondary Outcome
Title Percentage Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Weeks 24, 48
Hide Description Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value is the the latest pre-dose assessment (Day 1). Percentage change from Baseline was calculated as 100 multiplied by ([post-dose visit value minus Baseline value] divided by Baseline value). Lipid last observation carried forwardd (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Participants on lipid-lowering agents at Baseline were excluded.
Time Frame Baseline (Day 1) and at Weeks 24, 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
Arm/Group Title DTG + 3TC DTG + TDF/FTC
Hide Arm/Group Description:
Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks.
Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily for 48 weeks.
Overall Number of Participants Analyzed 360 359
Mean (Standard Deviation)
Unit of Measure: Percentage change
Total/HDL Cholesterol Ratio, Week 24, n=298, 310 Number Analyzed 298 participants 310 participants
-4.4  (22.53) -7.5  (17.90)
Total/HDL Cholesterol Ratio, Week 48, n=298, 307 Number Analyzed 298 participants 307 participants
-2.8  (17.86) -4.5  (18.25)
23.Secondary Outcome
Title Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Weeks 24, 48
Hide Description Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Weeks 24 and 48 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 48 or those who had Baseline lipids-lowering agents were not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values.
Time Frame Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).
Arm/Group Title DTG + 3TC DTG + TDF/FTC
Hide Arm/Group Description:
Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks.
Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily for 48 weeks.
Overall Number of Participants Analyzed 360 359
Measure Type: Number
Unit of Measure: Percentage of participants
Week 24, n=313, 320 Number Analyzed 313 participants 320 participants
4 0
Week 48, n=324, 332 Number Analyzed 324 participants 332 participants
4 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.5
Confidence Interval (2-Sided) 95%
1.5 to 5.6
Estimation Comments Week 24
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.037
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.8
Confidence Interval (2-Sided) 95%
0.2 to 5.4
Estimation Comments Week 48
24.Secondary Outcome
Title Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24
Hide Description Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200 cells/mm^3, >200 cells/mm^3 for group-1), Baseline HIV-1 RNA (<=100000, >100000 c/mL) and Race (White, African American/African heritage, Asian other).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
Arm/Group Title DTG + 3TC DTG + TDF/FTC
Hide Arm/Group Description:
Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks.
Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily for 48 weeks.
Overall Number of Participants Analyzed 360 359
Measure Type: Number
Unit of Measure: Percentage of participants
Baseline CD4+ cell count Group-1, <=200,n=32,26 Number Analyzed 32 participants 26 participants
78 92
Baseline CD4+ cell count Group-1, >200,n=328,333 Number Analyzed 328 participants 333 participants
95 94
Female, n=54, 46 Number Analyzed 54 participants 46 participants
93 89
Male, n=306, 313 Number Analyzed 306 participants 313 participants
94 95
Age, <35,n= 209, 203 Number Analyzed 209 participants 203 participants
93 94
Age, 35 to <50,n=115, 122 Number Analyzed 115 participants 122 participants
96 94
Age, >=50, n=36, 34 Number Analyzed 36 participants 34 participants
94 91
Baseline plasma HIV-1 RNA, <=100000,n=294,282 Number Analyzed 294 participants 282 participants
94 95
Baseline plasma HIV-1 RNA, >100000,n=66, 77 Number Analyzed 66 participants 77 participants
92 90
Race, White, n=237,249 Number Analyzed 237 participants 249 participants
95 95
Race, African American/African H., n=55, 40 Number Analyzed 55 participants 40 participants
89 90
Race, Asian, n=34, 30 Number Analyzed 34 participants 30 participants
97 90
Race, Other, n=34, 40 Number Analyzed 34 participants 40 participants
91 93
25.Secondary Outcome
Title Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48
Hide Description Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200 cells/mm^3, >200 cells/mm^3 for group-1), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian and other).
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
Arm/Group Title DTG + 3TC DTG + TDF/FTC
Hide Arm/Group Description:
Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks.
Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily for 48 weeks.
Overall Number of Participants Analyzed 360 359
Measure Type: Number
Unit of Measure: Percentage of participants
Baseline CD4+ cell count Group-1, <=200,n=32, 26 Number Analyzed 32 participants 26 participants
78 96
Baseline CD4+ cell count Group-1, >200,n=328,333 Number Analyzed 328 participants 333 participants
95 94
Female, n=54, 46 Number Analyzed 54 participants 46 participants
89 87
Male, n=306, 313 Number Analyzed 306 participants 313 participants
94 95
Age, <35,n= 209,203 Number Analyzed 209 participants 203 participants
92 94
Age, 35 to <50,n=115, 122 Number Analyzed 115 participants 122 participants
97 94
Age, >=50, n=36, 34 Number Analyzed 36 participants 34 participants
89 94
Baseline plasma HIV-1 RNA, <=100000,n=294,282 Number Analyzed 294 participants 282 participants
92 95
Baseline plasma HIV-1 RNA, >100000,n=66, 77 Number Analyzed 66 participants 77 participants
97 90
Race, White, n=237,249 Number Analyzed 237 participants 249 participants
96 96
Race, African American/African H., n=55, 40 Number Analyzed 55 participants 40 participants
80 88
Race, Asian, n=34, 30 Number Analyzed 34 participants 30 participants
97 90
Race, Other, n=34, 40 Number Analyzed 34 participants 40 participants
88 90
26.Secondary Outcome
Title Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups
Hide Description CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the inidicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from Analysis of Covariance (ANCOVA) model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only.
Time Frame Baseline (Day 1) and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
Arm/Group Title DTG + 3TC DTG + TDF/FTC
Hide Arm/Group Description:
Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks.
Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily for 48 weeks.
Overall Number of Participants Analyzed 360 359
Least Squares Mean (Standard Error)
Unit of Measure: Cells/mm^3
Baseline plasma HIV-1 RNA,<=100000, n=273,271 Number Analyzed 273 participants 271 participants
215.6  (10.67) 208.7  (10.71)
Baseline plasma HIV-1 RNA,>100000, n=64,69 Number Analyzed 64 participants 69 participants
261.8  (22.27) 248.7  (21.30)
Baseline CD4+ cell count,<=200, n=28, 25 Number Analyzed 28 participants 25 participants
210.9  (33.42) 153.2  (35.29)
Baseline CD4+ cell count,>200, n=309, 315 Number Analyzed 309 participants 315 participants
225.8  (10.00) 221.7  (9.89)
Age group-1, <35,n= 193, 191 Number Analyzed 193 participants 191 participants
234.2  (12.67) 201.7  (12.72)
Age group-1, 35 to <50, n=112, 117 Number Analyzed 112 participants 117 participants
212.7  (16.59) 244.2  (16.31)
Age group-1, >=50, n=32, 32 Number Analyzed 32 participants 32 participants
209.1  (31.20) 203.9  (31.06)
Age group-2, <50,n= 305, 308 Number Analyzed 305 participants 308 participants
226.4  (10.09) 217.8  (10.03)
Age group-2, >=50, n= 32, 32 Number Analyzed 32 participants 32 participants
208.5  (31.27) 204.1  (31.14)
Female, n=48, 41 Number Analyzed 48 participants 41 participants
236.2  (25.35) 263.6  (27.50)
Male, n=289, 299 Number Analyzed 289 participants 299 participants
222.8  (10.33) 210.0  (10.17)
Race group, White, n=227, 241 Number Analyzed 227 participants 241 participants
223.3  (11.70) 214.2  (11.38)
Race group, African Am/African H., n=45, 36 Number Analyzed 45 participants 36 participants
214.0  (26.25) 233.7  (29.39)
Race group, Asian, n=33, 27 Number Analyzed 33 participants 27 participants
205.0  (30.92) 189.3  (33.90)
Race group, Other, n=32, 36 Number Analyzed 32 participants 36 participants
270.2  (31.16) 235.3  (29.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 6.9
Confidence Interval (2-Sided) 95%
-22.7 to 36.6
Estimation Comments Baseline plasma HIV-1 RNA,<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 13.2
Confidence Interval (2-Sided) 95%
-46.8 to 73.2
Estimation Comments Baseline plasma HIV-1 RNA,>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and Baseline plasma HIV-1 RNA interaction.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 57.7
Confidence Interval (2-Sided) 95%
-37.2 to 152.5
Estimation Comments Baseline CD4+ cell count,<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 4.1
Confidence Interval (2-Sided) 95%
-23.5 to 31.7
Estimation Comments Baseline CD4+ cell count,>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 32.5
Confidence Interval (2-Sided) 95%
-2.7 to 67.7
Estimation Comments Age Group-1,<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -31.5
Confidence Interval (2-Sided) 95%
-77.1 to 14.2
Estimation Comments Age Group-1,35 to <50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 5.2
Confidence Interval (2-Sided) 95%
-81.4 to 91.8
Estimation Comments Age Group-1,>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -27.3
Confidence Interval (2-Sided) 95%
-100.8 to 46.1
Estimation Comments Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 12.8
Confidence Interval (2-Sided) 95%
-15.7 to 41.2
Estimation Comments Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 9.1
Confidence Interval (2-Sided) 95%
-22.9 to 41.1
Estimation Comments Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -19.8
Confidence Interval (2-Sided) 95%
-97.1 to 57.6
Estimation Comments Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 15.7
Confidence Interval (2-Sided) 95%
-74.4 to 105.9
Estimation Comments Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection DTG + 3TC, DTG + TDF/FTC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 35.0
Confidence Interval (2-Sided) 95%
-49.0 to 119.0
Estimation Comments Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.
27.Secondary Outcome
Title Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups
Hide Description CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only.
Time Frame Baseline (Day 1) and Week 24
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Hide Analysis Population Description
ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
Arm/Group Title DTG + 3TC DTG + TDF/FTC
Hide Arm/Group Description:
Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 48 weeks.
Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily for 48 weeks.
Overall Number of Participants Analyzed 360 359
Mean (Standard Error)
Unit of Measure: Cells/mm^3
Baseline plasma HIV-1 RNA,<=100000, n=283,273 Number Analyzed 283 participants 273 participants
186.01  (9.948) 148.21  (10.134)
Baseline plasma HIV-1 RNA,>100000, n=66,72 Number Analyzed 66 participants 72 participants
193.90  (20.811) 220.71  (19.814)
Baseline CD4+ cell count,<=200, n=29, 26 Number Analyzed 29 participants 26 participants
167.95  (31.308) 106.23  (32.990)
Baseline CD4+ cell count,>200, n=320, 319 Number Analyzed 320 participants 319 participants
189.91  (9.362) 167.35  (9.362)
Age group, <35,n= 201, 193 Number Analyzed 201 participants 193 participants
190.12  (11.829) 151.13  (12.050)
Age group-1, 35 to <50, n=113, 119 Number Analyzed 113 participants 119 participants
180.50  (15.733) 190.40  (15.404)
Age group-1, >=50, n=32, 32 Number Analyzed 32 participants 32 participants
198.74  (28.411) 133.21  (29.120)
Female, n=52, 42 Number Analyzed 52 participants 42 participants
213.58  (23.225) 153.92  (25.910)
Male, n=297, 303 Number Analyzed 297 participants 303 participants
183.41  (9.719) 164.18  (9.631)
Race group, White, n=233, 240 Number Analyzed 233 participants 240 participants
182.20  (10.987) 168.30  (10.846)
Race group, African Am/African H., n=51, 39 Number Analyzed 51 participants 39 participants
214.17  (23.472) 145.44  (26.841)
Race group, Asian, n=33, 28 Number Analyzed 33 participants 28 participants
154.14  (29.401) 141.22  (31.663)
Race group, Other, n=32, 38 Number Analyzed 32 participants 38 participants
222.24  (29.643) 163.05  (27.293)