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A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA)

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ClinicalTrials.gov Identifier: NCT01910402
Recruitment Status : Active, not recruiting
First Posted : July 29, 2013
Results First Posted : October 31, 2016
Last Update Posted : May 10, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Infection, Human Immunodeficiency Virus
Interventions Drug: Dolutegravir/abacavir/lamivudine FDC
Drug: Atazanavir
Drug: Ritonavir
Drug: Tenofovir/emtricitabine FDC
Enrollment 499

Recruitment Details The study consists of a Screening (14-28 days), Randomized (48 weeks) and Continuation (Cont.) Phase. Participants were said to have completed the study if they completed the Randomized phase and did not enter the Cont. Phase. Participants entering the Cont. Phase were said to have completed the study if they completed both phases of the study.
Pre-assignment Details A total of 499 participants were randomized to receive dolutegravir (DTG)/ abacavir (ABC)/ lamivudine (3TC) fixed dose combination (FDC) or combination of atazanavir (ATV), Ritonavir (RTV) and FDC of tenofovir disoproxil fumarate/emtricitabine (TDF/FTC). A total of 495 participants received at least single dose of investigational products (IP).
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Period Title: Randomized Phase
Started 248 247
Completed 206 192
Not Completed 42 55
Reason Not Completed
Adverse Event             10             18
Physician Decision             1             0
Lack of Efficacy             5             4
Lost to Follow-up             11             13
Protocol Violation             10             13
Withdrawal by Subject             5             7
Period Title: Continuation Phase
Started 120 0
Completed 30 0
Not Completed 90 0
Reason Not Completed
Ongoing             84             0
Adverse Event             1             0
Protocol Violation             3             0
Withdrawal by Subject             2             0
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD Total
Hide Arm/Group Description Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated. Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks. Total of all reporting groups
Overall Number of Baseline Participants 248 247 495
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 248 participants 247 participants 495 participants
38.1  (11.15) 37.8  (10.14) 37.9  (10.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 248 participants 247 participants 495 participants
Female
248
 100.0%
247
 100.0%
495
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 248 participants 247 participants 495 participants
African American/African Heritage 102 108 210
American Indian Or Alaskan Native 6 7 13
Asian - Central/South Asian Heritage 2 0 2
Asian - East Asian Heritage 0 1 1
Asian - South East Asian Heritage 20 22 42
Native Hawaiian Or Other Pacific Islander 1 0 1
White - Arabic/North African Heritage 3 3 6
White - White/Caucasian/European Heritage 112 104 216
Mixed Race 2 2 4
1.Primary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48
Hide Description Percentage of participants with plasma human immunodeficiency virus type 1(HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL) were assessed at Week 48 using the Snapshot algorithm. Analysis was performed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights, adjusting for Baseline plasma HIV-1 RNA ( =<vs. >100,000 c/mL) and CD4+ cell count (=<350 cells per millimetre cube (cells/mm^3) or >350 cells/mm^3). Intent-to-Treat Exposed (ITT-E) Population comprised of all randomised participants who received at least one dose of study medication.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 248 247
Measure Type: Number
Unit of Measure: Percentage of participants
82 71
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg QD, ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Hypothesis was to show that the antiviral effect of the DTG/ABC/3TC FDC administered QD was non-inferior to QD ATV+RTV+TDF/FTC FDC. Non-inferiority was concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms was greater than -12%
Statistical Test of Hypothesis P-Value 0.005
Comments If the primary and PP analyses both demonstrated non-inferiority, then as per pre-specified analysis, superiority of DTG/ABC/3TC FDC versus ATV+RTV+TDF/FTC FDC was tested in the ITT-E population at the 2-sided 5% level of significance.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in proportion
Estimated Value 10.5
Confidence Interval (2-Sided) 95%
3.1 to 17.8
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time
Hide Description Percentage of participants with plasma HIV-1 RNA <50 and <400 c/mL were assessed at Baseline, Week 4, 12, 24 , 36 and Week 48 using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). The Baseline value was defined as the latest pre-dose assessment (Day 1) value.
Time Frame Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it wasi) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 248 247
Measure Type: Number
Unit of Measure: Percentage of participants
HIV-1 RNA <50 c/mL, Baseline 0 0
HIV-1 RNA <50 c/mL, Week 4 64 13
HIV-1 RNA <50 c/mL, Week 12 81 49
HIV-1 RNA <50 c/mL, Week 24 85 77
HIV-1 RNA <50 c/mL, Week 36 85 77
HIV-1 RNA <50 c/mL, Week 48 82 71
HIV-1 RNA <400 c/mL, Baseline 0.8 0.8
HIV-1 RNA <400 c/mL, Week 4 90 54
HIV-1 RNA <400 c/mL, Week 12 91 84
HIV-1 RNA <400 c/mL, Week 24 88 82
HIV-1 RNA <400 c/mL, Week 36 86 81
HIV-1 RNA <400 c/mL, Week 48 83 76
3.Secondary Outcome
Title Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points
Hide Description Change from the Baseline in plasma HIV-1 RNA were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
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Hide Analysis Population Description
ITT-E Population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 248 247
Mean (Standard Deviation)
Unit of Measure: Log10 copies/mL
Baseline, n=248, 247 4.481  (0.8111) 4.441  (0.8023)
Week 4, n=245, 238 -2.646  (0.7971) -1.932  (0.5303)
Week 12, n=236, 226 -2.831  (0.8945) -2.585  (0.7321)
Week 24, n=225, 212 -2.868  (0.9196) -2.801  (0.8920)
Week 36, n=221, 204 -2.922  (0.8611) -2.851  (0.8470)
Week 48, n=207, 192 -2.960  (0.8033) -2.834  (0.8462)
4.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Indicated Timepoints
Hide Description Change from Baseline in cluster of differentiation 4(CD4+) cell count were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 248 247
Mean (Standard Deviation)
Unit of Measure: Cells per millimeter cube
Baseline, n=248, 247 369.7  (225.67) 380.3  (223.60)
Week 4, n=245, 237 94.9  (140.02) 73.7  (108.15)
Week 12, n=236, 224 143.8  (142.19) 124.4  (133.60)
Week 24, n=226, 210 200.6  (162.37) 163.0  (126.67)
Week 36, n=219, 204 230.7  (163.61) 191.4  (167.24)
Week 48, n=208, 191 248.8  (172.01) 230.7  (189.59)
5.Secondary Outcome
Title Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points
Hide Description Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in carbon dioxide, electrolytes (chloride, hyperkalemia, hypernatremia, hypokalemia, hyponatremia, phosphate, potassium, sodium), lipids (cholesterol [CHLS], high density lipoprotein [HDL] CHLS direct, low density lipoprotein (LDL) CHLS calculation, LDL CHLS direct, triglycerides), glucose (hyperglycaemia, hypoglycaemia) and urea are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Laboratory parameters were assessed in Safety Population which comprised of all participants who received at least one dose of study treatment. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline, Week 4, 12, 24, 36, 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. A value of "99999" indicates where no data is available or not able to determine the value.
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 248 247
Mean (Standard Deviation)
Unit of Measure: Millimoles per liter
Carbon Dioxide, Baseline, n= 248, 247 22.1  (2.37) 21.5  (2.28)
Carbon Dioxide, Week 4, n= 244, 237 -0.4  (2.29) 0.6  (2.2)
Carbon Dioxide, Week 12, n= 236, 226 -0.2  (2.2) 0.8  (2.19)
Carbon Dioxide, Week 24, n= 224, 212 -0.5  (2.31) 0.3  (2.38)
Carbon Dioxide, Week 36, n= 219, 204 0  (2.34) 0.6  (2.5)
Carbon Dioxide, Week 48, n= 208, 192 -0.6  (2.55) 0.4  (2.46)
Chloride, Baseline, n= 248, 247 104  (2.49) 104.6  (2.63)
Chloride, Week 4, n= 245, 237 0.6  (2.42) -0.5  (2.68)
Chloride, Week 12, n= 236, 226 1  (2.51) 0.2  (2.58)
Chloride, Week 24, n= 225, 212 0.7  (2.71) -0.1  (2.58)
Chloride, Week 36, n= 219, 204 0.9  (2.65) 0  (2.96)
Chloride, Week 48, n= 208, 192 0.7  (2.42) 0  (2.63)
CHLS, Baseline, n= 230, 232 4.351  (0.9389) 4.324  (0.9766)
CHLS, Week 4, n= 1, 3 -0.1  (99999) -0.017  (0.446)
CHLS, Week 12, n= 224, 221 0.298  (0.7492) -0.058  (0.7137)
CHLS, Week 24, n= 218, 201 0.317  (0.7254) -0.001  (0.7456)
CHLS, Week 36, n= 205, 191 0.33  (0.7328) 0  (0.7509)
CHLS, Week 48, n= 195, 175 0.447  (0.7441) 0.109  (0.7647)
Glucose, Baseline, n= 231, 234 4.91  (1.003) 4.88  (1.41)
Glucose, Week 12, n= 226, 224 0.3  (1.359) 0.22  (1.234)
Glucose, Week 24, n= 219, 204 0.17  (0.811) 0.26  (1.248)
Glucose, Week 36, n= 211, 196 0.17  (1.24) 0.34  (1.753)
Glucose, Week 48, n= 197, 180 0.18  (1.01) 0.24  (1.377)
HDL CHLS, Direct, Baseline, n= 230, 232 1.23  (0.3717) 1.235  (0.3953)
HDL CHLS, Direct, Week 4, n= 1, 3 -0.1  (99999) 0  (0.0529)
HDL CHLS, Direct, Week 12, n= 224, 221 0.182  (0.3407) 0.005  (0.2316)
HDL CHLS, Direct, Week 24, n= 218, 201 0.201  (0.2962) 0.053  (0.2819)
HDL CHLS, Direct, Week 36, n= 205, 191 0.204  (0.2943) 0.036  (0.2848)
HDL CHLS, Direct, Week 48, n= 195, 175 0.231  (0.2911) 0.081  (0.2964)
Hyperglycaemia, Baseline, n= 231, 234 4.91  (1.003) 4.88  (1.41)
Hyperglycaemia, Week 12, n= 226, 224 0.3  (1.359) 0.22  (1.234)
Hyperglycaemia, Week 24, n= 219, 204 0.17  (0.811) 0.26  (1.248)
Hyperglycaemia, Week 36, n= 211, 196 0.17  (1.24) 0.34  (1.753)
Hyperglycaemia, Week 48, n= 197, 180 0.18  (1.01) 0.24  (1.377)
Hyperkalemia, Baseline, n= 248, 247 4.11  (0.304) 4.08  (0.33)
Hyperkalemia, Week 4, n= 244, 237 -0.01  (0.344) 0.12  (0.367)
Hyperkalemia, Week 12, n= 236, 226 0.03  (0.355) 0.1  (0.39)
Hyperkalemia, Week 24, n= 224, 212 -0.04  (0.339) 0.06  (0.372)
Hyperkalemia, Week 36, n= 219, 204 0.03  (0.332) 0.13  (0.387)
Hyperkalemia, Week 48, n= 208, 192 -0.04  (0.346) 0.04  (0.372)
Hypernatremia, Baseline, n= 248, 247 137.6  (2.25) 137.8  (2.48)
Hypernatremia, Week 4, n= 245, 237 0  (2.11) -0.5  (2.4)
Hypernatremia, Week 12, n= 236, 226 0.7  (2.3) 0.1  (2.51)
Hypernatremia, Week 24, n= 225, 212 0.6  (2.3) 0.2  (2.11)
Hypernatremia, Week 36, n= 219, 204 0.9  (2.32) 0.2  (2.5)
Hypernatremia, Week 48, n= 208, 192 0.6  (2.24) 0.5  (2.39)
Hypoglycaemia, Baseline, n= 231, 234 4.91  (1.003) 4.88  (1.41)
Hypoglycaemia, Week 12, n= 226, 224 0.3  (1.359) 0.22  (1.234)
Hypoglycaemia, Week 24, n= 219, 204 0.17  (0.811) 0.26  (1.248)
Hypoglycaemia, Week 36, n= 211, 196 0.17  (1.24) 0.34  (1.753)
Hypoglycaemia, Week 48, n= 197, 180 0.18  (1.01) 0.24  (1.377)
Hypokalemia, Baseline, n= 248, 247 4.11  (0.304) 4.08  (0.33)
Hypokalemia, Week 4, n= 244, 237 -0.01  (0.344) 0.12  (0.367)
Hypokalemia, Week 12, n= 236, 226 0.03  (0.355) 0.1  (0.39)
Hypokalemia, Week 24, n= 224, 212 -0.04  (0.339) 0.06  (0.372)
Hypokalemia, Week 36, n= 219, 204 0.03  (0.332) 0.13  (0.387)
Hypokalemia, Week 48, n= 208, 192 -0.04  (0.346) 0.04  (0.372)
Hyponatremia, Baseline, n= 248, 247 137.6  (2.25) 137.8  (2.48)
Hyponatremia, Week 4, n= 245, 237 0  (2.11) -0.5  (2.4)
Hyponatremia, Week 12, n= 236, 226 0.7  (2.3) 0.1  (2.51)
Hyponatremia, Week 24, n= 225, 212 0.6  (2.3) 0.2  (2.11)
Hyponatremia, Week 36, n= 219, 204 0.9  (2.32) 0.2  (2.5)
Hyponatremia, Week 48, n= 208, 192 0.6  (2.24) 0.5  (2.39)
LDL CHLS Calculation, Baseline, n= 229, 231 2.513  (0.7912) 2.537  (0.8016)
LDL CHLS Calculation, Week 4, n= 1, 3 0.08  (99999) -0.123  (0.5255)
LDL CHLS Calculation, Week 12, n= 221, 219 0.125  (0.6045) -0.14  (0.6114)
LDL CHLS Calculation, Week 24, n= 213, 201 0.111  (0.6209) -0.111  (0.6188)
LDL CHLS Calculation, Week 36, n= 201, 188 0.112  (0.6385) -0.099  (0.6049)
LDL CHLS Calculation, Week 48, n= 190, 175 0.213  (0.6499) -0.021  (0.6227)
LDL CHLS, Direct, Baseline, n= 13, 7 2.522  (0.7586) 2.993  (0.7707)
LDL CHLS, Direct, Week 12, n= 0, 1 99999  (99999) -0.44  (99999)
LDL CHLS, Direct, Week 24, n= 1, 0 -0.64  (99999) 99999  (99999)
LDL CHLS, Direct, Week 36, n= 1, 0 -0.23  (99999) 99999  (99999)
LDL CHLS, Direct, Week 48, n= 0 99999  (99999) 99999  (99999)
Phosphate, Baseline, n= 248, 247 1.15  (0.1695) 1.142  (0.1732)
Phosphate, Week 4, n= 245, 237 0  (0.1461) -0.032  (0.1726)
Phosphate, Week 12, n= 236, 226 0.02  (0.1694) 0.026  (0.1634)
Phosphate, Week 24, n= 225, 212 0.021  (0.1628) 0.026  (0.1701)
Phosphate, Week 36, n= 219, 204 0.029  (0.1736) 0.009  (0.1675)
Phosphate, Week 48, n= 208, 192 0.016  (0.1736) 0  (0.1673)
Potassium, Baseline, n= 248, 247 4.11  (0.304) 4.08  (0.33)
Potassium, Week 4, n= 244, 237 -0.01  (0.344) 0.12  (0.367)
Potassium, Week 12, n= 236, 226 0.03  (0.355) 0.1  (0.39)
Potassium, Week 24, n= 224, 212 -0.04  (0.339) 0.06  (0.372)
Potassium, Week 36, n= 219, 204 0.03  (0.332) 0.13  (0.387)
Potassium, Week 48, n= 208, 192 -0.04  (0.346) 0.04  (0.372)
Sodium, Baseline, n= 248, 247 137.6  (2.25) 137.8  (2.48)
Sodium, Week 4, n= 245, 237 0  (2.11) -0.5  (2.4)
Sodium, Week 12, n= 236, 226 0.7  (2.3) 0.1  (2.51)
Sodium, Week 24, n= 225, 212 0.6  (2.3) 0.2  (2.11)
Sodium, Week 36, n= 219, 204 0.9  (2.32) 0.2  (2.5)
Sodium, Week 48, n= 208, 192 0.6  (2.24) 0.5  (2.39)
Triglycerides, Baseline, n= 230, 232 1.335  (0.8261) 1.217  (0.6642)
Triglycerides, Week 4, n= 1, 3 -0.18  (99999) 0.237  (0.2491)
Triglycerides, Week 12, n= 224, 221 -0.04  (0.6861) 0.167  (0.7074)
Triglycerides, Week 24, n= 218, 201 0.036  (0.7108) 0.125  (0.6132)
Triglycerides, Week 36, n= 205, 191 0.037  (0.6732) 0.157  (0.6785)
Triglycerides, Week 48, n= 195, 175 0.018  (0.8158) 0.107  (0.5527)
Urea, Baseline, n= 248, 247 4.28  (1.329) 4.43  (1.518)
Urea, Week 4, n= 245, 237 -0.04  (1.085) 0.1  (1.313)
Urea, Week 12, n= 236, 226 0.08  (1.097) 0.16  (1.409)
Urea, Week 24, n= 225, 212 0.03  (1.187) 0.12  (1.283)
Urea, Week 36, n= 219, 204 0.08  (1.236) -0.03  (1.256)
Urea, Week 48, n= 208, 192 0.1  (1.162) 0.02  (1.179)
6.Secondary Outcome
Title Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints.
Hide Description Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in bilirubin and creatinine are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline, Week 4, 12, 24, 36, 48
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Hide Analysis Population Description
Safety Population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 248 247
Mean (Standard Deviation)
Unit of Measure: Micromoles per liter
Bilirubin, Baseline, n= 248, 247 7.4  (3.2) 7.5  (3.11)
Bilirubin, Week 4, n= 244, 237 -0.8  (2.59) 27.2  (23.15)
Bilirubin, Week 12, n= 236, 226 -0.6  (2.65) 22.8  (16.49)
Bilirubin, Week 24, n= 225, 212 -0.2  (3.06) 25  (18.38)
Bilirubin, Week 36, n= 219, 204 -0.2  (3.01) 23.8  (16.31)
Bilirubin, Week 48, n= 208, 192 -0.3  (3.08) 23.7  (17)
Creatinine, Baseline, n= 248, 247 58.29  (12.035) 61.56  (15.43)
Creatinine, Week 4, n= 245, 237 8.4  (7.057) 4.89  (7.109)
Creatinine, Week 12, n= 236, 226 9.2  (8.288) 5.83  (8.357)
Creatinine, Week 24, n= 225, 212 9.16  (9.983) 5.8  (8.063)
Creatinine, Week 36, n= 219, 204 10.08  (10.473) 5.37  (9.013)
Creatinine, Week 48, n= 208, 192 9.29  (8.614) 5.86  (10.252)
7.Secondary Outcome
Title Change From Baseline in Albumin at Indicated Timepoints.
Hide Description Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in albumin is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline, Week 4, 12, 24, 36, 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 248 247
Mean (Standard Deviation)
Unit of Measure: Grams per liter
Baseline, n= 248, 247 41.3  (4.39) 41.5  (3.88)
Week 4, n= 245, 237 0.1  (2.36) -0.5  (2.59)
Week 12, n= 236, 226 0.5  (2.95) 0.1  (2.59)
Week 24, n= 225, 212 1.4  (3.2) 0.8  (2.95)
Week 36, n= 219, 204 1.4  (3.09) 0.6  (2.96)
Week 48, n= 208, 192 1.7  (3.17) 1.3  (3.04)
8.Secondary Outcome
Title Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points
Hide Description Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline, Week 4, 12, 24, 36, 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 248 247
Mean (Standard Deviation)
Unit of Measure: International units per liter
Alanine aminotransferase, Baseline, n= 248, 247 22.5  (26.69) 22.3  (20.47)
Alanine aminotransferase, Week 4, n= 245, 237 -3.3  (27.54) -3.4  (15.86)
Alanine aminotransferase, Week 12, n= 236, 226 -5.2  (27.51) -2.3  (20.26)
Alanine aminotransferase, Week 24, n= 225, 212 -5.4  (27.92) -3.7  (20.7)
Alanine aminotransferase, Week 36, n= 219, 204 -4.9  (36.11) -5.3  (20.08)
Alanine aminotransferase, Week 48, n= 208, 192 -5.7  (28.54) -1.5  (31.53)
Alkaline phosphatase, Baseline, n= 248, 247 72.7  (22.75) 72  (30.26)
Alkaline phosphatase, Week 4, n= 245, 237 -1.5  (14.56) 9.4  (28.69)
Alkaline phosphatase, Week 12, n= 236, 226 -2.1  (17.1) 15.1  (30.82)
Alkaline phosphatase, Week 24, n= 225, 212 0.5  (17.86) 22.4  (41.59)
Alkaline phosphatase, Week 36, n= 219, 204 0.6  (19.19) 20.4  (30.7)
Alkaline phosphatase, Week 48, n= 208, 192 2.9  (28.05) 21.9  (25.35)
Aspartate aminotransferase, Baseline, n= 248, 247 28.7  (22.11) 28.3  (19.77)
Aspartate aminotransferase, Week 4, n= 244, 237 -3.3  (29.8) -3.6  (18.83)
Aspartate aminotransferase, Week 12, n= 236, 226 -6.2  (21.11) -4  (13.79)
Aspartate aminotransferase, Week 24, n= 224, 212 -6.3  (22.44) -5.1  (13.8)
Aspartate aminotransferase, Week 36, n= 219, 204 -6.4  (31.42) -6.5  (16.63)
Aspartate aminotransferase, Week 48, n= 208, 192 -7.5  (22.19) -3.7  (25.28)
Creatine Kinase, Baseline, n= 248, 247 97.4  (88.55) 105.5  (100.51)
Creatine Kinase, Week 4, n= 245, 237 -0.3  (68.72) 35.6  (549.1)
Creatine Kinase, Week 12, n= 236, 226 6.9  (73.7) 7.3  (90.39)
Creatine Kinase, Week 24, n= 225, 212 10.3  (88.66) 5.8  (77.12)
Creatine Kinase, Week 36, n= 219, 204 11.9  (155.68) 7.2  (132.74)
Creatine Kinase, Week 48, n= 208, 192 23.8  (242.66) 3.8  (98.58)
9.Secondary Outcome
Title Change From Baseline in Creatinine Clearance at Indicated Time Points
Hide Description Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in creatinine clearance is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline, Week 4, 12, 24, 36, 48
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Hide Analysis Population Description
Safety Population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 248 247
Mean (Standard Deviation)
Unit of Measure: Milliliter per minute
Baseline, n= 248, 247 132.1  (42.95) 128.7  (45.96)
Week 4, n= 245, 237 -16.3  (15.03) -7.5  (12.91)
Week 12, n= 236, 226 -17.3  (17.01) -7  (23.14)
Week 24, n= 225, 212 -16.2  (20.36) -9.1  (16.88)
Week 36, n= 219, 204 -16.8  (22.35) -7.5  (17.67)
Week 48, n= 208, 192 -15.9  (19.62) -7.7  (18.42)
10.Secondary Outcome
Title Change From Baseline in Lipase at Indicated Timepoints.
Hide Description Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in lipase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline, Week 4, 12, 24, 36, 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 248 247
Mean (Standard Deviation)
Unit of Measure: Units per liter
Baseline, n= 248, 247 32.9  (24.67) 32.3  (22.14)
Week 4, n= 245, 237 -1.2  (15.06) -1.3  (15.81)
Week 12, n= 236, 226 -2.2  (22.74) -2.1  (29)
Week 24, n= 225, 212 -6  (21.05) -6  (18.57)
Week 36, n= 219, 204 -6.3  (25.62) -6.3  (21.36)
Week 48, n= 208, 192 -6.5  (29.63) -7.8  (20.72)
11.Secondary Outcome
Title Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints.
Hide Description Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in Total CHLS/HDL CHLS ratio is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline, Week 4, 12, 24, 36, 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 248 247
Mean (Standard Deviation)
Unit of Measure: Ratio
Baseline, n= 247, 245 3.78841  (1.33327) 3.84622  (2.6556)
Week 4, n= 1, 4 0.1264  (99999) 0.21588  (0.60727)
Week 12, n= 233, 223 -0.2736  (1.0283) -0.1092  (0.73776)
Week 24, n= 224, 209 -0.3098  (1.11093) -0.1922  (0.79848)
Week 36, n= 212, 198 -0.3286  (1.01181) -0.1433  (0.79498)
Week 48, n= 207, 186 -0.2886  (1.01415) -0.1444  (1.23362)
12.Secondary Outcome
Title Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points
Hide Description Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline, Week 4, 12, 24, 36, 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 248 247
Mean (Standard Deviation)
Unit of Measure: 10^9 cells per liter
Basophils, Baseline, n= 248, 247 0.017  (0.0139) 0.017  (0.0127)
Basophils, Week 4, n= 241, 234 0.003  (0.0182) 0.003  (0.0198)
Basophils, Week 12, n= 228, 216 0.002  (0.0174) 0.003  (0.0162)
Basophils, Week 24, n= 221, 208 0.004  (0.0187) 0.003  (0.0155)
Basophils, Week 36, n= 214, 203 0.004  (0.0182) 0.003  (0.0158)
Basophils, Week 48, n= 206, 189 0.005  (0.0199) 0.006  (0.0146)
Eosinophils, Baseline, n= 248, 247 0.139  (0.1790) 0.146  (0.2580)
Eosinophils, Week 4, n= 241, 234 0.040  (0.1486) 0.021  (0.1648)
Eosinophils, Week 12, n= 228, 216 0.037  (0.1982) -0.001  (0.1610)
Eosinophils, Week 24, n= 221, 208 0.028  (0.1927) 0.005  (0.1973)
Eosinophils, Week 36, n= 214, 203 0.048  (0.2244) 0.014  (0.2139)
Eosinophils, Week 48, n= 206, 189 0.030  (0.1744) 0.007  (0.2274)
Lymphocytes, Baseline, n= 248, 247 1.538  (0.6092) 1.573  (0.7895)
Lymphocytes, Week 4, n= 241, 234 0.208  (0.4914) 0.119  (0.5493)
Lymphocytes, Week 12, n= 228, 216 0.257  (0.5500) 0.156  (0.6690)
Lymphocytes, Week 24, n= 221, 208 0.317  (0.4889) 0.192  (0.5910)
Lymphocytes, Week 36, n= 214, 203 0.362  (0.5199) 0.178  (0.6441)
Lymphocytes, Week 48, n= 206, 189 0.359  (0.5235) 0.261  (0.7098)
Monocytes, Baseline, n= 248, 247 0.315  (0.1491) 0.326  (0.1606)
Monocytes, Week 4, n= 241, 234 -0.001  (0.1558) -0.015  (0.1391)
Monocytes, Week 12, n= 228, 216 -0.010  (0.1412) -0.031  (0.1369)
Monocytes, Week 24, n= 221, 208 0.008  (0.1498) -0.015  (0.1581)
Monocytes, Week 36, n= 214, 203 -0.006  (0.1448) -0.028  (0.1500)
Monocytes, Week 48, n= 206, 189 0.001  (0.1379) -0.024  (0.1638)
13.Secondary Outcome
Title Change From Baseline in Erythrocytes at Indicated Time Points.
Hide Description Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline, Week 4, 12, 24, 36, 48
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Hide Analysis Population Description
Safety Population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 248 247
Mean (Standard Deviation)
Unit of Measure: 10^12 per liter
Baseline, n= 248, 247 4.27  (0.467) 4.28  (0.440)
Week 4, n= 243, 234 -0.04  (0.244) -0.07  (0.239)
Week 12, n= 233, 220 -0.07  (0.351) -0.09  (0.308)
Week 24, n= 225, 211 -0.08  (0.373) -0.09  (0.329)
Week 36, n= 218, 203 -0.10  (0.384) -0.08  (0.358)
Week 48, n= 207, 190 -0.10  (0.365) -0.05  (0.318)
14.Secondary Outcome
Title Change From Baseline in Hematocrit Count at Indicated Time Points.
Hide Description Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in hematocrit is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline, Week 4, 12, 24, 36, 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 248 247
Mean (Standard Deviation)
Unit of Measure: Fraction of 1
Baseline, n= 248, 247 0.3757  (0.03978) 0.3766  (0.03675)
Week 4, n= 243, 234 0.0003  (0.02176) -0.0042  (0.02238)
Week 12, n= 233, 220 0.0081  (0.03157) 0.0000  (0.02646)
Week 24, n= 225, 211 0.0157  (0.03209) 0.0051  (0.03083)
Week 36, n= 218, 203 0.0167  (0.03451) 0.0062  (0.03379)
Week 48, n= 207, 190 0.0212  (0.03293) 0.0107  (0.03200)
15.Secondary Outcome
Title Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points.
Hide Description Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocyte mean corpuscular volume (EMCV) is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline, Week 4, 12, 24, 36, 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 248 247
Mean (Standard Deviation)
Unit of Measure: Femtoliter
Baseline, n= 248, 247 88.4  (6.45) 88.4  (7.01)
Week 4, n= 243, 234 0.9  (1.81) 0.5  (1.83)
Week 12, n= 233, 220 3.4  (2.98) 1.9  (2.94)
Week 24, n= 225, 211 5.5  (4.03) 3.1  (4.33)
Week 36, n= 218, 203 6.0  (4.04) 3.1  (5.22)
Week 48, n= 207, 190 7.1  (4.31) 3.7  (5.15)
16.Secondary Outcome
Title Change From Baseline in Triglycerides at Week 48
Hide Description Change from Baseline in mean triglycerides is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted triglycerides at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides at Baseline. Subjects on lipid lowering therapy at baseline were excluded from analysis. Measurements collected after a subject initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36.
Time Frame Baseline and Week 48
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Hide Analysis Population Description
Safety Population. Subjects on lipid lowering therapy at baseline were excluded from analysis.
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 226 214
Least Squares Mean (Standard Error)
Unit of Measure: Millimoles per liter
0.045  (0.0477) 0.070  (0.0477)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg QD, ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7053
Comments [Not Specified]
Method Multiple Imputed Dataset - MAR
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.026
Confidence Interval (2-Sided) 95%
-0.159 to 0.107
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline in TC/HDL Ratio at Week 48
Hide Description Change from Baseline in mean total cholesterol (TC)/HDL ratio is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted TC/HDL at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides/HDL at Baseline. Subjects on lipid lowering therapy at baseline were excluded from analysis. Measurements collected after a subject initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36.
Time Frame Baseline and Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Subjects on lipid lowering therapy at baseline were excluded from analysis.
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 226 214
Least Squares Mean (Standard Error)
Unit of Measure: Ratio
-0.264  (0.0707) -0.158  (0.0784)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg QD, ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3165
Comments [Not Specified]
Method Multiple Imputed Dataset - MAR
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.106
Confidence Interval (2-Sided) 95%
-0.313 to 0.101
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points
Hide Description Change from Baseline in urine albumin creatinine ratio at Week 24 and Week 48 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed.
Time Frame Baseline, Week 24, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 248 247
Mean (Standard Deviation)
Unit of Measure: milligrams per millimole
Baseline, n= 221, 231 5.69  (27.277) 3.44  (8.520)
Week 24, n= 179, 186 -1.15  (16.557) -1.03  (9.091)
Week 48, n= 170, 164 -0.68  (20.597) -0.10  (9.393)
19.Secondary Outcome
Title Summary of AEs by Maximum Toxicity as Per DAIDS AE Grading Table.
Hide Description Number of participants with Grade 1-4 AEs were assessed from the start of study treatment and until end of the Randimization phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening.
Time Frame Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 248 247
Measure Type: Number
Unit of Measure: Participants
Grade 1 79 60
Grade 2 94 91
Grade 3 18 37
Grade 4 3 9
20.Secondary Outcome
Title Number of Participants With Any Adverse Events (AEs), and Serious Adverse Events (SAEs)
Hide Description An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented.
Time Frame From start of IP through the Study Phase (Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC)
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Safety Population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 248 247
Measure Type: Number
Unit of Measure: Participants
Any AEs 132 160
Any SAEs 16 20
21.Secondary Outcome
Title Summary of Maximum Post-Baseline Emergent Chemistry Toxicities
Hide Description Number of participants with Grade 1-4 emergent chemistry toxicities were assessed from the start of study treatment and until the follow up contact. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening.
Time Frame Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated..
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 248 247
Measure Type: Number
Unit of Measure: Participants
Hyperglycaemia, Grade 1 23 15
Hyperglycaemia, Grade 2 21 15
Hyperglycaemia, Grade 3 4 3
Hyperglycaemia, Grade 4 1 0
Hyperkalemia, Grade 1 1 0
Hyperkalemia, Grade 2 0 1
Hyperkalemia, Grade 3 0 0
Hyperkalemia, Grade 4 0 0
Hypernatremia, Grade 1 1 0
Hypernatremia, Grade 2 0 0
Hypernatremia, Grade 3 0 0
Hypernatremia, Grade 4 0 0
Hypoglycaemia, Grade 1 9 7
Hypoglycaemia, Grade 2 4 1
Hypoglycaemia, Grade 3 1 0
Hypoglycaemia, Grade 4 0 0
Hypokalemia, Grade 1 18 21
Hypokalemia, Grade 2 1 0
Hypokalemia, Grade 3 0 0
Hypokalemia, Grade 4 0 0
Hyponatremia, Grade 1 79 82
Hyponatremia, Grade 2 1 0
Hyponatremia, Grade 3 0 0
Hyponatremia, Grade 4 0 0
Alanine aminotransferase, Grade 1 7 11
Alanine aminotransferase, Grade 2 8 5
Alanine aminotransferase, Grade 3 1 2
Alanine aminotransferase, Grade 4 1 0
Albumin, Grade 1 6 2
Albumin, Grade 2 1 4
Albumin, Grade 3 0 0
Albumin, Grade 4 0 0
Alkaline phosphatase, Grade 1 4 17
Alkaline phosphatase, Grade 2 2 1
Alkaline phosphatase, Grade 3 0 0
Alkaline phosphatase, Grade 4 0 0
Aspartate aminotransferase, Grade 1 17 14
Aspartate aminotransferase, Grade 2 8 5
Aspartate aminotransferase, Grade 3 1 2
Aspartate aminotransferase, Grade 4 1 0
Bilirubin, Grade 1 2 52
Bilirubin, Grade 2 0 86
Bilirubin, Grade 3 0 57
Bilirubin, Grade 4 0 5
Carbon dioxide, Grade 1 94 74
Carbon dioxide, Grade 2 5 4
Carbon dioxide, Grade 3 0 0
Carbon dioxide, Grade 4 0 0
Cholesterol, Grade 1 74 47
Cholesterol, Grade 2 32 13
Cholesterol, Grade 3 4 2
Cholesterol, Grade 4 0 0
Creatine kinase, Grade 1 4 7
Creatine kinase, Grade 2 1 1
Creatine kinase, Grade 3 4 0
Creatine kinase, Grade 4 0 1
Creatinine, Grade 1 5 8
Creatinine, Grade 2 0 3
Creatinine, Grade 3 1 0
Creatinine, Grade 4 0 0
LDL cholesterol calculation, Grade 1 53 31
LDL cholesterol calculation, Grade 2 15 11
LDL cholesterol calculation, Grade 3 7 3
LDL cholesterol calculation, Grade 4 0 0
LDL cholesterol direct, Grade 1 3 1
LDL cholesterol direct, Grade 2 1 0
LDL cholesterol direct, Grade 3 0 0
LDL cholesterol direct, Grade 4 0 0
Lipase, Grade 1 16 11
Lipase, Grade 2 11 5
Lipase, Grade 3 3 2
Lipase, Grade 4 0 1
Phosphate, Grade 1 5 12
Phosphate, Grade 2 9 13
Phosphate, Grade 3 1 2
Phosphate, Grade 4 0 0
Potassium, Grade 1 19 21
Potassium, Grade 2 1 1
Potassium, Grade 3 0 0
Potassium, Grade 4 0 0
Sodium, Grade 1 80 82
Sodium, Grade 2 1 0
Sodium, Grade 3 0 0
Sodium, Grade 4 0 0
Triglycerides, Grade 1 0 0
Triglycerides, Grade 2 5 2
Triglycerides, Grade 3 2 0
Triglycerides, Grade 4 0 0
Glucose, Grade 1 28 21
Glucose, Grade 2 24 14
Glucose, Grade 3 4 3
Glucose, Grade 4 1 0
22.Secondary Outcome
Title Summary of Maximum Post-Baseline Emergent Hematology Toxicities
Hide Description Number of participants with Grade 1-4 emergent hematology toxicities were assessed from the start of study treatment and until the follow up contact. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening.
Time Frame Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 248 247
Measure Type: Number
Unit of Measure: Participants
Hemoglobin, Grade 1 21 30
Hemoglobin, Grade 2 4 3
Hemoglobin, Grade 3 1 1
Hemoglobin, Grade 4 0 0
Leukocytes, Grade 1 6 6
Leukocytes, Grade 2 1 2
Leukocytes, Grade 3 0 0
Leukocytes, Grade 4 0 0
Neutrophils, Grade 1 19 14
Neutrophils, Grade 2 7 9
Neutrophils, Grade 3 0 3
Neutrophils, Grade 4 1 1
Platelets, Grade 1 9 1
Platelets, Grade 2 0 4
Platelets, Grade 3 1 0
Platelets, Grade 4 0 0
23.Secondary Outcome
Title Number of Participants Who Withdrew From Treatment Due to AEs
Hide Description An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.
Time Frame average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 248 247
Measure Type: Number
Unit of Measure: Participants
11 17
24.Secondary Outcome
Title Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints
Hide Description Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.
Time Frame Baseline, Week 24, 48
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Hide Analysis Population Description
Safety Population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 248 247
Mean (Standard Deviation)
Unit of Measure: Micrograms per liter
BSAP, Baseline, n=244, 243 11.52  (3.837) 11.67  (5.287)
BSAP, Week 24, n=219, 207 1.33  (3.934) 6.00  (5.962)
BSAP, Week 48, n=202, 184 2.64  (5.746) 7.60  (7.144)
Osteocalcin, Baseline, n=235, 235 16.60  (8.551) 18.27  (19.891)
Osteocalcin, Week 24, n=209, 197 3.73  (7.484) 14.38  (22.205)
Osteocalcin, Week 48, n=194, 178 5.15  (9.018) 16.30  (25.043)
PTP, Baseline, n=246, 240 49.4  (24.48) 49.5  (23.01)
PTP, Week 24, n=223, 206 10.1  (20.11) 32.0  (27.89)
PTP, Week 48, n=205, 186 11.2  (23.05) 34.1  (27.28)
25.Secondary Outcome
Title Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints
Hide Description Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in Type I collagen C-telopeptides (T-1 CCT) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.
Time Frame Baseline, Week 24, 48
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Hide Analysis Population Description
Safety Population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 248 247
Mean (Standard Deviation)
Unit of Measure: Nanograms per liter
Baseline, n=245, 243 312.9  (183.68) 329.7  (190.02)
Week 24, n=221, 207 89.8  (173.09) 272.4  (205.22)
Week 48, n=202, 185 75.9  (173.73) 267.9  (200.82)
26.Secondary Outcome
Title Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48
Hide Description Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in vitamin D and vitamin D2 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.
Time Frame Baseline, Weeks 24, 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 248 247
Mean (Standard Deviation)
Unit of Measure: Nanomoles per liter
Vitamin D, Baseline, n=247, 244 58.6  (30.15) 56.9  (22.43)
Vitamin D, Week 24, n=223, 208 1.8  (24.95) 16.3  (31.66)
Vitamin D, Week 48, n=206, 186 -1.9  (20.63) 8.9  (23.78)
Vitamin D2, Baseline, n=247, 244 9.3  (3.16) 9.5  (3.79)
Vitamin D2, Week 24, n=223, 208 0.3  (6.04) 1.0  (7.88)
Vitamin D2, Week 48, n=206, 186 0.1  (4.71) 0.9  (11.00)
Vitamin D3, Baseline, n=247, 244 58.1  (30.07) 56.1  (22.59)
Vitamin D3, Week 24, n=223, 208 1.5  (24.33) 15.2  (31.39)
Vitamin D3, Week 48, n=206, 186 -1.9  (20.56) 7.9  (21.72)
27.Secondary Outcome
Title Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline
Hide Description Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP), Type 1 Collagen C-Telopeptide, vitamin D ratio of Week 48 results over Baseline is calculated. Bone biomarkers were analysed based on log transformed data. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed. Estimates of adjusted mean and difference were calculated from an ANCOVA model adjusting for age, baseline viral load Baseline CD4+ cell count, Baseline biomarker level, body mass index category, smoking status and baseline Vitamin D use. Adjusted mean of log-transformed change from Baseline are transformed back to Week 48/Baseline ratio for each treatment group. Adjusted difference of log-transformed change from Baseline between treatment groups is transformed back to the ratio of Week 48/Baseline ratio in DTG/ABC/3TC FDC to ATV+RTV+TDF/FTC FDC.
Time Frame Baseline, Weeks 24, 48
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Hide Analysis Population Description
Safety Population.
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated..
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 248 247
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Ratio
BSAP, n=202, 183
1.188
(1.135 to 1.243)
1.629
(1.553 to 1.708)
PTP, n=202, 184
1.214
(1.158 to 1.272)
1.752
(1.668 to 1.840)
Osteocalcin, n=194, 178
1.282
(1.214 to 1.354)
2.039
(1.926 to 2.159)
Type 1 Collagen C-Telopeptide, n=202, 184
1.257
(1.195 to 1.323)
1.918
(1.819 to 2.023)
Vitamin D, n=206, 186
0.987
(0.940 to 1.036)
1.158
(1.101 to 1.219)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg QD, ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of ratio
Estimated Value 0.729
Confidence Interval (2-Sided) 95%
0.683 to 0.779
Estimation Comments BSAP ratio of Week 48 result over Baseline
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg QD, ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of ratio
Estimated Value 0.693
Confidence Interval (2-Sided) 95%
0.647 to 0.741
Estimation Comments PTP ratio of Week 48 result over Baseline
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg QD, ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of ratio
Estimated Value 0.629
Confidence Interval (2-Sided) 95%
0.581 to 0.680
Estimation Comments Osteocalcin ratio of Week 48 result over Baseline
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg QD, ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of ratio
Estimated Value 0.655
Confidence Interval (2-Sided) 95%
0.609 to 0.706
Estimation Comments Type 1 Collagen C-Telopeptide ratio of Week 48 result over Baseline
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg QD, ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of ratio
Estimated Value 0.852
Confidence Interval (2-Sided) 95%
0.794 to 0.914
Estimation Comments Vitamin D ratio of Week 48 result over Baseline
28.Secondary Outcome
Title Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS
Hide Description The SF-12 is the 12 item abbreviated form of SF-36 survey. It provides information about how participants feel, and how well they have been able to perform their usual activities. SF-12 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health . Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.
Time Frame Baseline and Week 48
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ITT-E Population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 248 247
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Total Score, Baseline, n=245, 240 38.6  (4.33) 38.5  (4.47)
Total Score, Week 48, n=205, 192 0.0  (5.15) 0.1  (5.66)
MCS, Baseline, n=245, 240 48.310  (10.3025) 47.670  (10.4284)
MCS, Week 48, n=205, 192 2.397  (10.5232) 2.329  (9.9782)
PCS, Baseline, n=245, 240 50.663  (8.4227) 50.374  (8.0038)
PCS, Week 48, n=205, 192 1.905  (8.6309) 1.444  (8.3938)
29.Secondary Outcome
Title Assessment of HIVTSQs Total Score at Indicated Timepoints.
Hide Description The HIV treatment satisfaction questionnaire (HIVTSQ) is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g. convenience, flexibility. The HIVTSQ items are summed up to produce a treatment satisfaction score (0 to 60) and an individual satisfaction rating for each item (0 to 6) and two subscales: general satisfaction/clinical and lifestyle/ease subscales. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Statistical analysis was performed based on Wilcoxon rank sum test. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.
Time Frame Week 4, 12, 24, 48
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Hide Analysis Population Description
ITT-E Population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 248 247
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Week 4, n=243, 239 54.0  (6.37) 51.9  (8.53)
Week 12, n=236, 226 56.1  (5.38) 53.6  (7.67)
Week 24, n=225, 211 56.8  (4.55) 54.3  (7.27)
Week 48, n=206, 191 57.0  (4.38) 55.4  (6.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg QD, ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments Week 4
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg QD, ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 12
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg QD, ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Week 24
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection DTG 50 mg/ABC 600 mg/3TC 300 mg QD, ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments Week 48
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
30.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups
Hide Description Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 by subgroups (age, race, country, Baseline plasma HIV-1 RNA (BPHR), Baseline CD4+ cell count (BCCC), Baseline Centers for Disease Control and Prevention (CDC) category and HIV-1 subtype) were assessed using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). Analysis was performed using a stratified analysis with CMH weights, adjusting for Baseline plasma HIV-1 RNA ( =<vs. >100,000 c/mL) and CD4+ cell count (=<350 cells/mm^3 or >350 cells/mm^3). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.
Time Frame Week 48
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Hide Analysis Population Description
ITT-E Population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 248 247
Measure Type: Number
Unit of Measure: Percentage of participants
Age, <50 Years, n=212, 212 80 71
Age, >=50 Years, n=36, 35 92 74
Race, White, n=115, 107 86 80
Race, Non-White, n=133,140 78 64
Race, African-American/African Heritage, n=102,108 74 67
Non-African-American/African Heritage, n=146, 139 88 75
BPHR, <1000, n=5, 10 60 80
BPHR, 1000 to <10,000, n=66, 62 83 77
BPHR, 10,000 to <50,000, n=83, 81 84 74
BPHR, 50,000 to <=100,000, n=25, 28 80 64
BPHR, >100,000, n=69, 66 80 64
BCCC, <200, n=64, 49 81 69
BCCC, >=200, n=184, 198 82 72
BCCC, <50, n=9, 15 67 60
BCCC, 50 to <200, n=55, 34 84 74
BCCC, 200 to <350, n=66, 74 89 73
BCCC, 350 to <500, n=56, 65 79 74
BCCC, >=500, n=62, 59 77 68
CDC category, A, n=210, 208 81 71
CDC category, B, n=27, 30 81 77
CDC category, C, n=11, 9 91 56
HIV-1 subtype: B vs Non-B, B, n=95, 111 80 69
IV-1 subtype: B vs Non-B, non-B, n=140, 131 84 73
31.Secondary Outcome
Title Number of Participants With Post-Baseline HIV-1 Disease Progression
Hide Description Number of participants with post-Baseline HIV-1disease progression were assessed during study period. The CDC Classification System for HIV Infection is the medical classification system used by the United States Centers for Disease Control and Prevention (CDC) to classify HIV disease and infection. The clinical categories of HIV infection are defined as follows: Category A: Mildly symptomatic, Category B: Moderately symptomatic, Category C: Severely symptomatic. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.
Time Frame Up to week 48
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Hide Analysis Population Description
ITT-E Population, only those participants who experienced a disease progression to CDC Class C or death were analyzed.
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 7 7
Measure Type: Number
Unit of Measure: Participants
CDC Class A to CDC Class C 5 4
CDC Class B to CDC Class C 1 2
CDC Class C to new CDC Class C 0 0
CDC Class A, B or C to Death 1 1
32.Secondary Outcome
Title Number of Participants With Treatment Emergent Resistances
Hide Description Number of participants, who meet confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to INI, NNRTI, NRTI, PI will be summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. On-treatment Genotypic Resistance Population comprised of all participants in the ITT-E population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met.
Time Frame Up to week 48
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Hide Analysis Population Description
On-treatment Genotypic Resistance Population
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description:
Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Overall Number of Participants Analyzed 6 4
Measure Type: Number
Unit of Measure: Participants
Any mutation 0 1
INSTI 0 0
NRTI 0 1
M184M/I/V 0 1
PI 0 1
Time Frame AEs and SAEs were collected from start of study treatment until end of study treatment (average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC)
Adverse Event Reporting Description On-treatment SAEs and non-serious AEs are reported for the Safety Population, which comprises of all randomized participants who received at least one dose of study treatment. AEs were identified post-hoc for two ATV+RTV+TDF/FTC FDC subjects at one site. These AEs are not included and are not considered to affect the overall safety findings.
 
Arm/Group Title DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Hide Arm/Group Description Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TD FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TD FDC was discontinued/terminated. Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
All-Cause Mortality
DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Affected / at Risk (%) Affected / at Risk (%)
Total   16/248 (6.45%)   20/247 (8.10%) 
Cardiac disorders     
Acute coronary syndrome  1  1/248 (0.40%)  0/247 (0.00%) 
Acute myocardial infarction  1  1/248 (0.40%)  0/247 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  1/248 (0.40%)  1/247 (0.40%) 
Nausea  1  0/248 (0.00%)  1/247 (0.40%) 
Vomiting  1  0/248 (0.00%)  1/247 (0.40%) 
General disorders     
Death  1  1/248 (0.40%)  0/247 (0.00%) 
Hepatobiliary disorders     
Cholecystitis chronic  1  0/248 (0.00%)  1/247 (0.40%) 
Hepatitis acute  1  0/248 (0.00%)  1/247 (0.40%) 
Infections and infestations     
Pneumonia  1  1/248 (0.40%)  2/247 (0.81%) 
Arthritis infective  1  0/248 (0.00%)  1/247 (0.40%) 
Bacteraemia  1  1/248 (0.40%)  0/247 (0.00%) 
Cellulitis  1  0/248 (0.00%)  1/247 (0.40%) 
Herpes simplex  1  0/248 (0.00%)  1/247 (0.40%) 
Infected skin ulcer  1  1/248 (0.40%)  0/247 (0.00%) 
Lower respiratory tract infection  1  1/248 (0.40%)  0/247 (0.00%) 
Malaria  1  1/248 (0.40%)  0/247 (0.00%) 
Mastoiditis  1  1/248 (0.40%)  0/247 (0.00%) 
Meningitis viral  1  0/248 (0.00%)  1/247 (0.40%) 
Otitis media chronic  1  1/248 (0.40%)  0/247 (0.00%) 
Pneumocystis jirovecii pneumonia  1  1/248 (0.40%)  0/247 (0.00%) 
Salpingitis  1  1/248 (0.40%)  0/247 (0.00%) 
Injury, poisoning and procedural complications     
Ankle fracture  1  1/248 (0.40%)  0/247 (0.00%) 
Thermal burn  1  1/248 (0.40%)  0/247 (0.00%) 
Toxicity to various agents  1  1/248 (0.40%)  0/247 (0.00%) 
Investigations     
Blood creatinine increased  1  0/248 (0.00%)  1/247 (0.40%) 
Metabolism and nutrition disorders     
Diabetic ketoacidosis  1  0/248 (0.00%)  1/247 (0.40%) 
Electrolyte imbalance  1  1/248 (0.40%)  0/247 (0.00%) 
Musculoskeletal and connective tissue disorders     
Osteonecrosis  1  0/248 (0.00%)  1/247 (0.40%) 
Scleroderma  1  0/248 (0.00%)  1/247 (0.40%) 
Nervous system disorders     
Amnesia  1  1/248 (0.40%)  0/247 (0.00%) 
Cerebrovascular accident  1  1/248 (0.40%)  0/247 (0.00%) 
Seizure  1  0/248 (0.00%)  1/247 (0.40%) 
Transient ischaemic attack  1  0/248 (0.00%)  1/247 (0.40%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  0/248 (0.00%)  1/247 (0.40%) 
Psychiatric disorders     
Acute psychosis  1  0/248 (0.00%)  1/247 (0.40%) 
Intentional self-injury  1  0/248 (0.00%)  1/247 (0.40%) 
Panic attack  1  1/248 (0.40%)  0/247 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  1  1/248 (0.40%)  0/247 (0.00%) 
Chronic kidney disease  1  1/248 (0.40%)  0/247 (0.00%) 
Reproductive system and breast disorders     
Endometriosis  1  0/248 (0.00%)  1/247 (0.40%) 
Rectocele  1  0/248 (0.00%)  1/247 (0.40%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/248 (0.00%)  1/247 (0.40%) 
Skin and subcutaneous tissue disorders     
Angioedema  1  1/248 (0.40%)  0/247 (0.00%) 
Diabetic foot  1  1/248 (0.40%)  0/247 (0.00%) 
Skin ulcer  1  0/248 (0.00%)  1/247 (0.40%) 
Vascular disorders     
Hypertensive emergency  1  1/248 (0.40%)  0/247 (0.00%) 
Peripheral artery stenosis  1  0/248 (0.00%)  1/247 (0.40%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
Affected / at Risk (%) Affected / at Risk (%)
Total   132/248 (53.23%)   160/247 (64.78%) 
Eye disorders     
Ocular icterus  1  0/248 (0.00%)  18/247 (7.29%) 
Gastrointestinal disorders     
Nausea  1  47/248 (18.95%)  48/247 (19.43%) 
Diarrhoea  1  24/248 (9.68%)  32/247 (12.96%) 
Dyspepsia  1  9/248 (3.63%)  25/247 (10.12%) 
Vomiting  1  17/248 (6.85%)  17/247 (6.88%) 
Abdominal pain  1  8/248 (3.23%)  17/247 (6.88%) 
General disorders     
Fatigue  1  8/248 (3.23%)  14/247 (5.67%) 
Hepatobiliary disorders     
Jaundice  1  0/248 (0.00%)  14/247 (5.67%) 
Hyperbilirubinaemia  1  0/248 (0.00%)  13/247 (5.26%) 
Infections and infestations     
Upper respiratory tract infection  1  19/248 (7.66%)  20/247 (8.10%) 
Nasopharyngitis  1  16/248 (6.45%)  14/247 (5.67%) 
Urinary tract infection  1  13/248 (5.24%)  16/247 (6.48%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  13/248 (5.24%)  17/247 (6.88%) 
Nervous system disorders     
Headache  1  29/248 (11.69%)  32/247 (12.96%) 
Dizziness  1  13/248 (5.24%)  15/247 (6.07%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  10/248 (4.03%)  26/247 (10.53%) 
Skin and subcutaneous tissue disorders     
Rash  1  12/248 (4.84%)  20/247 (8.10%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01910402     History of Changes
Other Study ID Numbers: 117172
First Submitted: July 25, 2013
First Posted: July 29, 2013
Results First Submitted: July 25, 2016
Results First Posted: October 31, 2016
Last Update Posted: May 10, 2018