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A Phase IIIb Study of the Safety, Efficacy, and Tolerability of Switching to a Fixed-dose Combination of Abacavir/Dolutegravir/ Lamivudine From Current Antiretroviral Regimen

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ClinicalTrials.gov Identifier: NCT02105987
Recruitment Status : Completed
First Posted : April 7, 2014
Results First Posted : February 25, 2016
Last Update Posted : January 4, 2017
Sponsor:
Collaborators:
PPD
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: ABC/DTG/3TC FDC
Drug: Ongoing cART regimen
Enrollment 555
Recruitment Details  
Pre-assignment Details 841 participants (par.) were screened and 555 human immunodeficiency virus type 1 (HIV-1) infected par. who were on stable suppressive combination antiretroviral therapy (cART) with 2 nucleoside reverse transcriptase inhibitor (NRTIs) plus either a protease inhibitor (PI), an non-NRTI (NNRTI), or an integrase inhibitor (INI) were randomized.
Arm/Group Title ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Current ART ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Early Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Late Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Early Switch:Cont Phase ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Late Switch:Cont Phase
Hide Arm/Group Description Participants received abacavir (ABC) 600 milligrams (mg)/ dolutegravir (DTG) 50 mg/ lamivudine (3TC) 300 mg fixed-dose combination (FDC) tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. Participants continued on their current ART regimen for 24 weeks. Participants who completed early switch phase continued to receive ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for an additional 24 weeks. Participants who completed early switch phase and maintained viral suppression (<50 Copies per milliliter [c/mL]) were switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment. If ABC/DTG/3TC was not locally approved and commercially available when a participant successfully completed the Week 48 visit, the participant had the opportunity to enter into the Continuation Phase. During the Continuation Phase, participants were supplied with ABC/DTG/3TC until it was locally approved and commercially available. If ABC/DTG/3TC was not locally approved and commercially available when a participant successfully completed the Week 48 visit, the participant had the opportunity to enter into the Continuation Phase. During the Continuation Phase, participants were supplied with ABC/DTG/3TC until it was locally approved and commercially available.
Period Title: Early Switch Phase (24 Weeks)
Started 275 [1] 278 [1] 0 0 0 0
Completed 239 244 0 0 0 0
Not Completed 36 34 0 0 0 0
Reason Not Completed
Adverse Event             10             0             0             0             0             0
Protocol Violation             15             17             0             0             0             0
Withdrawal by Subject             4             10             0             0             0             0
Lost to Follow-up             3             3             0             0             0             0
Physician Decision             4             3             0             0             0             0
Missing Disposition Data             0             1             0             0             0             0
[1]
Number Started represents the number of par. in the Intent-To-Treat Exposed (ITT-E) Population.
Period Title: Late Switch Phase (24 Weeks)
Started 0 0 275 244 0 0
Completed 0 0 230 230 0 0
Not Completed 0 0 45 14 0 0
Reason Not Completed
Adverse Event             0             0             10             4             0             0
Protocol Violation             0             0             15             1             0             0
Withdrawal by Subject             0             0             6             5             0             0
Lost to Follow-up             0             0             8             3             0             0
Physician Decision             0             0             5             0             0             0
met protocol defined stopping criteria             0             0             0             1             0             0
Per sponsor request             0             0             1             0             0             0
Period Title: Continuation Phase
Started 0 0 0 0 14 23
Completed 0 0 0 0 13 23
Not Completed 0 0 0 0 1 0
Reason Not Completed
Protocol Violation             0             0             0             0             1             0
Arm/Group Title Early Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Late Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Total
Hide Arm/Group Description Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks. Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment. Total of all reporting groups
Overall Number of Baseline Participants 275 244 519
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 275 participants 244 participants 519 participants
44.1  (10.61) 45.5  (11.25) 44.8  (10.93)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 275 participants 244 participants 519 participants
Female
38
  13.8%
32
  13.1%
70
  13.5%
Male
237
  86.2%
212
  86.9%
449
  86.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 275 participants 244 participants 519 participants
African American/African Heritage 81 63 144
American Indian or Alaska Native 3 2 5
Asian - Central/South Asian Heritage 1 2 3
Asian - East Asian Heritage 1 3 4
Asian - Japanese Heritage 1 1 2
Asian - South East Asian Heritage 1 2 3
Asian - Mixed Race 1 0 1
Native Hawaiian or other Pacific Islander 1 1 2
White - Arabic/North African Heritage 2 0 2
White - White/Caucasian/European Heritage 176 165 341
White - Mixed Race 3 3 6
White - Asian 1 1 2
Mixed Race 1 1 2
Missing 2 0 2
1.Primary Outcome
Title Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies Per Milliliter (c/mL) at Week 24 Using the Snapshot Algorithm
Hide Description The Food and Drug Administration (FDA) snapshot (Missing, Switch or Discontinuation = Failure) algorithm is intended to be primarily a virologic assessment of the endpoint, and as such follows a “virology first” hierarchy. Virologic Success (e.g., <50 c/mL) or virologic failure within an analysis window is typically determined by the last available HIV-1 RNA measurement in that window and in the treatment phase of interest (e.g., Week 24 snapshot outcomes of the early switch phase will not use HIV-1 RNA data from the late switch phase, even if such data is within the Week 24 analysis window). A virologic failure occurs when a participant changes to their ART regimen (e.g., addition of other ARTs to the study-specified regimens, or switches in components of the current ART regimen).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Exposed (ITT-E) Population: all participants randomized to ABC/DTG/3TC and receive at least one dose of study drug or randomized to remain on current ART regimen and continue in the study past Day 1.
Arm/Group Title ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Current ART
Hide Arm/Group Description:
Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Overall Number of Participants Analyzed 275 278
Measure Type: Number
Unit of Measure: Participants
233 245
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC 600 mg / DTG 50 mg /3TC 300 mg FDC, Current ART
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority margin is -10%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.4
Confidence Interval (2-Sided) 95%
-9.1 to 2.4
Estimation Comments Based on Cochran-Mantel Haenszel stratified analysis adjusting for the following Baseline stratification factor: Original ART third agent class (PI, NNRTI, or INI).
2.Secondary Outcome
Title Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 24
Hide Description Change from Baseline in CD4+ cell counts were assessed at Baseline, Weeks 4, 8, 16 and 24. No imputation for missing data or premature discontinuation was performed and the observed values were used. Baseline value is defined as the last pre-treatment value observed. Change from Baseline was calculated as the observed value minus the Baseline value. The Week 24 data were summarized.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Only participants with non-missing CD4 data at Week 24 are included.
Arm/Group Title ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Current ART
Hide Arm/Group Description:
Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Overall Number of Participants Analyzed 238 248
Median (Inter-Quartile Range)
Unit of Measure: Cells per cubic millimeter (cells/mm^3)
50.0
(-48.0 to 130.0)
11.0
(-60.0 to 103.5)
3.Secondary Outcome
Title Number of Participants in the Virologic Non-response Category From the Snapshot Analysis at Week 24
Hide Description Virologic non-responders were defined as the participants with a viral load >=50 c/mL in the Week 24 analysis window. Virologic non-response includes participants who had HIV-1 RNA >=50 c/mL, who discontinued for lack of efficacy, who discontinued for other reasons while not suppressed, data in window but not <50 c/mL, and who changed ART regimen at Week 24. Difference is calculated as the proportion on ABC/DTG/3TC - proportion on current ART regimen.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Current ART
Hide Arm/Group Description:
Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Overall Number of Participants Analyzed 275 278
Measure Type: Number
Unit of Measure: Participants
3 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC 600 mg / DTG 50 mg /3TC 300 mg FDC, Current ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-2.0 to 1.4
Estimation Comments Based on Cochran-Mantel Haenszel stratified analysis adjusting for the following Baseline stratification factor: Original ART third agent class (PI, NNRTI, or INI).
4.Secondary Outcome
Title Number of Participants With Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) up to 24 Weeks
Hide Description An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An 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, is a congenital anomaly/birth defect, based on medical or scientific judgment and all events of possible drug-induced liver injury with hyperbilirubinemia. The DAIDS table for grading the severity of adult and pediatric AEs was utilized for AE reporting. The DAIDS estimates the severity grade as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening) for each parameter.
Time Frame Baseline and up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least one dose of study drug.
Arm/Group Title ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Current ART
Hide Arm/Group Description:
Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Overall Number of Participants Analyzed 276 277
Measure Type: Number
Unit of Measure: Participants
Any AEs 183 129
Any SAEs 6 5
5.Secondary Outcome
Title Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to 24 Weeks
Hide Description The number of participants with maximum post-Baseline emergent chemistry toxicities for each grade were summarized by parameter. A toxicity is considered emergent if it develops or increases in intensity from Baseline. For participants who were originally randomized to current ART regimen on Day 1 and then switched to ABC/DTG/3TC on Week 24, Baseline is defined as the last non-missing value from the early switch phase and maximum post-Baseline emergent during the late switch phase was determined relative to this Baseline. The DAIDS table for grading the severity of adult and pediatric AEs was utilized for AE reporting. The DAIDS defined the severity grade as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening) for each parameter.
Time Frame Baseline and up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Current ART
Hide Arm/Group Description:
Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Overall Number of Participants Analyzed 276 277
Measure Type: Number
Unit of Measure: Participants
Grade 1 98 108
Grade 2 73 71
Grade 3 21 25
Grade 4 10 10
6.Secondary Outcome
Title Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to 24 Weeks
Hide Description The number of participants with maximum post-Baseline emergent hematology toxicities for each grade were summarized by parameter. A toxicity is considered emergent if it develops or increases in intensity from Baseline. For participants who were originally randomized to current ART regimen on Day 1 and then switched to ABC/DTG/3TC on Week 24, Baseline is defined as the last non-missing value from the early switch phase and maximum post-Baseline emergent during the late switch phase was determined relative to this Baseline. The DAIDS table for grading the severity of adult and pediatric AEs was utilized for AE reporting. The DAIDS defined the severity grade as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening) for each parameter.
Time Frame Baseline and up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Current ART
Hide Arm/Group Description:
Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Overall Number of Participants Analyzed 276 277
Measure Type: Number
Unit of Measure: Participants
Grade 1 19 15
Grade 2 3 6
Grade 3 0 2
Grade 4 1 0
7.Secondary Outcome
Title Number of Participants With AEs Leading to Withdrawal Over 24 Weeks
Hide Description An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An 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, is a congenital anomaly/birth defect, based on medical or scientific judgment and all events of possible drug-induced liver injury with hyperbilirubinemia.
Time Frame Baseline and up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Current ART
Hide Arm/Group Description:
Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Overall Number of Participants Analyzed 276 277
Measure Type: Number
Unit of Measure: Participants
11 0
8.Secondary Outcome
Title Change From Baseline in Fasting Lipids (Cholesterol, LDL Cholesterol, HDL Cholesterol, and Triglycerides) at Week 24
Hide Description Change from Baseline for each fasting lipid parameters included cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides. Adjusted mean is the estimated mean change from Baseline in each parameter at Week 24 in each arm calculated from an analysis of covariance (ANCOVA) model which includes the following covariates: treatment, original ART third agent class, interaction of treatment and original ART 3rd agent, use of lipid modifying agent and Baseline lipid level. Difference is calculated as ABC/DTG/3TC - Current ART regimen. For fasting lipid assessments, an overnight fast is preferred; however, a minimum of a 6-hour fast was acceptable for participants with afternoon appointments.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Arm/Group Title ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Current ART
Hide Arm/Group Description:
Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Overall Number of Participants Analyzed 276 277
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Millimoles per liter (mmol/L)
Cholesterol,n=226, 231
0.10
(0.00 to 0.21)
-0.01
(-0.11 to 0.10)
LDL Cholesterol, n=221, 226
0.10
(0.01 to 0.18)
0.02
(-0.06 to 0.11)
HDL Cholesterol, n=226, 231
0.00
(-0.04 to 0.03)
-0.03
(-0.06 to 0.01)
Triglycerides, n=226, 231
0.07
(-0.07 to 0.21)
-0.04
(-0.17 to 0.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC 600 mg / DTG 50 mg /3TC 300 mg FDC, Current ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.096
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
-0.02 to 0.23
Estimation Comments Statistical analysis of cholesterol is presented
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ABC 600 mg / DTG 50 mg /3TC 300 mg FDC, Current ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.167
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
-0.03 to 0.18
Estimation Comments Statistical analysis of LDL cholesterol is presented
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ABC 600 mg / DTG 50 mg /3TC 300 mg FDC, Current ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.317
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.02 to 0.06
Estimation Comments Statistical analysis of HDL cholesterol is presented
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ABC 600 mg / DTG 50 mg /3TC 300 mg FDC, Current ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.187
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
-0.05 to 0.27
Estimation Comments Statistical analysis of triglycerides is presented
9.Secondary Outcome
Title Change From Baseline in Fasting Lipids (Total Cholesterol/HDL Cholesterol Ratio) at Week 24
Hide Description Change from Baseline for fasting lipid parameter total cholesterol/HDL cholesterol ratio. Adjusted mean is the estimated mean change from Baseline at Week 24 in each arm calculated from an analysis of covariance (ANCOVA) model which includes the following covariates: treatment, original ART third agent class, interaction of treatment and original ART 3rd agent, use of lipid modifying agent and Baseline lipid level. Difference is calculated as ABC/DTG/3TC - Current ART regimen. For fasting lipid assessments, an overnight fast is preferred; however, a minimum of a 6-hour fast was acceptable for participants with afternoon appointments.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the specified time points.
Arm/Group Title ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Current ART
Hide Arm/Group Description:
Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Overall Number of Participants Analyzed 226 231
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Ratio
0.10
(-0.02 to 0.22)
0.00
(-0.12 to 0.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC 600 mg / DTG 50 mg /3TC 300 mg FDC, Current ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.175
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
-0.04 to 0.25
Estimation Comments Statistical analysis of total cholesterol/HDL cholesterol ratio is presented
10.Secondary Outcome
Title Change From Baseline in Treatment Satisfaction at Week 4 and Week 24
Hide Description The HIV treatment satisfaction questionnaire (TSQ) is a 10 item self-reported scale. Individual item scores range from 6 (very satisfied) to 0 (very dissatisfied). The treatment satisfaction total score (range 0-60) is the sum of all the 10 individual items. The general satisfaction/Clinical subscale (range 0-30) is the sum of the 5 clinical items and the lifestyle/ease subscale (range 0-30) is the sum of the remaining 5 lifestyle items. Last observation carried forward (LOCF) were used for the analysis. If a participant had a missing value at Week 24, his previous non-missing available value while on the same treatment was carried forward (ie the Week 4 or withdrawal value is used in the Week 24 summary for participants in the ABC/DTG3TC with missing Week 24 value). Data were analyzed using an ANCOVA model with factors including treatment, Baseline score and stratification factor. Treatment group difference (ABC/DTG/3TC-cART) estimate and 95% CI were presented.
Time Frame Baseline, Week 4 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Arm/Group Title ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Current ART
Hide Arm/Group Description:
Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Overall Number of Participants Analyzed 275 278
Mean (Standard Error)
Unit of Measure: Units on a scale
Total score, n=270,276 3.2  (0.40) 0.8  (0.39)
General Satisfaction/Clinical Subscale, n=269, 276 1.3  (0.24) 0.2  (0.23)
Lifestyle/Ease Subscale Score, n=269, 276 1.8  (0.19) 0.6  (0.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC 600 mg / DTG 50 mg /3TC 300 mg FDC, Current ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.4
Confidence Interval (2-Sided) 95%
1.3 to 3.5
Estimation Comments Statistical analysis for total score is presented
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ABC 600 mg / DTG 50 mg /3TC 300 mg FDC, Current ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.4 to 1.7
Estimation Comments Statistical analysis for general satisfaction/clinical subscale score is presented
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ABC 600 mg / DTG 50 mg /3TC 300 mg FDC, Current ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
0.8 to 1.8
Estimation Comments Statistical analysis for lifestyle/ease subscale is presented
11.Secondary Outcome
Title Change From Baseline in Creatinine at Week 24
Hide Description Renal markers included creatinine and summarized based on an observed case (OC) data set at Week 24. Adjusted mean is the estimated mean change from Baseline in each biomarker at Week 24 in each arm calculated from an ANCOVA analysis of covariance model including the following covariates: treatment, original ART third agent class, interaction of treatment and original ART third agent class, and Baseline biomarker level. Differences are calculated as ABC/DTG/3TC - Current ART regimen.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only participants with a non-missing value at Week 24 are included.
Arm/Group Title ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Current ART
Hide Arm/Group Description:
Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Overall Number of Participants Analyzed 240 249
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Micromoles per liter (umol/L)
7.63
(6.46 to 8.80)
1.12
(-0.03 to 2.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC 600 mg / DTG 50 mg /3TC 300 mg FDC, Current ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.51
Confidence Interval (2-Sided) 95%
4.86 to 8.16
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Glomerular Filtration Rate (GFR) From Creatinine Adjusted Using CKD-EPI Equation at Week 24
Hide Description Renal markers included GFR from creatinine adjusted using chronic kidney disease epidemiology collaboration (CKD-EPI) equation and summarized based on an OC data set at Week 24. Adjusted mean is the estimated mean change from Baseline in each biomarker at Week 24 in each arm calculated from an ANCOVA analysis of covariance model including the following covariates: treatment, original ART third agent class, interaction of treatment and original ART third agent class, and Baseline biomarker level. Differences are calculated as ABC/DTG/3TC - Current ART regimen.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only participants with a non-missing value at Week 24 are included.
Arm/Group Title ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Current ART
Hide Arm/Group Description:
Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Overall Number of Participants Analyzed 240 249
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mL/second
-8.05
(-9.30 to -6.80)
-1.18
(-2.41 to 0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC 600 mg / DTG 50 mg /3TC 300 mg FDC, Current ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.87
Confidence Interval (2-Sided) 95%
-8.64 to -5.11
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in GFR From Creatinine Adjusted Using MDRD Enzymatic Equation at Week 24
Hide Description Renal markers included GFR from creatinine adjusted using modification of diet in renal disease (MDRD) enzymatic equation and summarized based on an OC data set at Week 24. Adjusted mean is the estimated mean change from Baseline in each biomarker at Week 24 in each arm calculated from an ANCOVA analysis of covariance model including the following covariates: treatment, original ART third agent class, interaction of treatment and original ART third agent class, and Baseline biomarker level. Differences are calculated as ABC/DTG/3TC - Current ART regimen.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only participants with a non-missing value at Week 24 are included.
Arm/Group Title ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Current ART
Hide Arm/Group Description:
Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Overall Number of Participants Analyzed 239 249
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mL/second/1.73 meter square
-0.16
(-0.18 to -0.13)
-0.02
(-0.04 to 0.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC 600 mg / DTG 50 mg /3TC 300 mg FDC, Current ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.13
Confidence Interval (2-Sided) 95%
-0.17 to -0.10
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Urea at Week 24
Hide Description Renal markers included urea and summarized based on an OC data set at Week 24. Adjusted mean is the estimated mean change from Baseline in each biomarker at Week 24 in each arm calculated from an ANCOVA analysis of covariance model including the following covariates: treatment, original ART third agent class, interaction of treatment and original ART third agent class, and Baseline biomarker level. Differences are calculated as ABC/DTG/3TC - Current ART regimen.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only participants with a non-missing value at Week 24 are included.
Arm/Group Title ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Current ART
Hide Arm/Group Description:
Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Overall Number of Participants Analyzed 240 249
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Millimoles per liter (mmol/L)
-0.03
(-0.18 to 0.12)
0.07
(-0.08 to 0.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC 600 mg / DTG 50 mg /3TC 300 mg FDC, Current ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.375
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.10
Confidence Interval (2-Sided) 95%
-0.31 to 0.12
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in Urine Albumin/Creatinine Ratio at Week 24
Hide Description Renal markers included urine albumin/creatinine ratioand summarized based on an OC data set at Week 24. Adjusted mean is the estimated mean change from Baseline in each biomarker at Week 24 in each arm calculated from an ANCOVA analysis of covariance model including the following covariates: treatment, original ART third agent class, interaction of treatment and original ART third agent class, and Baseline biomarker level. Differences are calculated as ABC/DTG/3TC - Current ART regimen.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only participants with a non-missing value at Week 24 are included.
Arm/Group Title ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Current ART
Hide Arm/Group Description:
Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Overall Number of Participants Analyzed 197 222
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Gram per mole (G/mol) creatinine
0.11
(-0.70 to 0.92)
-0.07
(-0.84 to 0.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC 600 mg / DTG 50 mg /3TC 300 mg FDC, Current ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.749
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.18
Confidence Interval (2-Sided) 95%
-0.93 to 1.30
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Percent Change From Baseline in Bone Marker Analytes at Week 24
Hide Description Outcome Measure Description: Bone biomarkers analytes include bone specific alkaline phosphatase, osteocalcin, procollagen 1 n-terminal propeptide, type I collagen c-telopeptides and were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, age, sex (male or female), body mass index (BMI) (<25 kilogram per meter [kg/m] or >=25 kg/m), smoking status (never smoked or former smoker or current smoker), Baseline vitamin D (no vitamin D use at Baseline or vitamin D use at Baseline), and Baseline biomarker level.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Arm/Group Title ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Current ART
Hide Arm/Group Description:
Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Overall Number of Participants Analyzed 276 277
Geometric Mean (95% Confidence Interval)
Unit of Measure: Percent
Bone specific alkaline phosphatase, n= 214, 224
0.84
(0.79 to 0.88)
0.98
(0.93 to 1.03)
Osteocalcin, n=211, 221
0.87
(0.82 to 0.93)
0.96
(0.90 to 1.03)
Procollagen 1 n-terminal propeptide, n=212, 222
0.88
(0.83 to 0.94)
0.96
(0.91 to 1.03)
Type I collagen c-telopeptides, n=212, 223
0.87
(0.79 to 0.95)
1.03
(0.94 to 1.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC 600 mg / DTG 50 mg /3TC 300 mg FDC, Current ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Bone specific alkaline phosphatase
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.82 to 0.90
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ABC 600 mg / DTG 50 mg /3TC 300 mg FDC, Current ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Osteocalcin
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.85 to 0.96
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ABC 600 mg / DTG 50 mg /3TC 300 mg FDC, Current ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments Procollagen 1 n-terminal propeptide
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.15 to -0.04
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ABC 600 mg / DTG 50 mg /3TC 300 mg FDC, Current ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments Type I collagen c-telopeptides
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.86 to 0.96
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Percent Change From Baseline in Cardiovascular Marker Analytes at Week 24
Hide Description Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or African American, Other), and Baseline biomarker level.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Arm/Group Title ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Current ART
Hide Arm/Group Description:
Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Overall Number of Participants Analyzed 276 277
Geometric Mean (95% Confidence Interval)
Unit of Measure: Percent
Fatty acid binding protein 2 [ng/L], n=212,222
0.67
(0.59 to 0.75)
1.04
(0.92 to 1.17)
Interleukin 6 [ng/L], n=213,222
0.86
(0.74 to 0.99)
0.80
(0.69 to 0.92)
Soluble cd14 [ng/L], n=214,223
0.76
(0.73 to 0.79)
0.82
(0.79 to 0.85)
Soluble vasc cell adhesion mol 1[ng/L], n=213,222
0.86
(0.80 to 0.92)
0.85
(0.80 to 0.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC 600 mg / DTG 50 mg /3TC 300 mg FDC, Current ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Fatty acid binding protein 2
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean ratio
Estimated Value 0.64
Confidence Interval (2-Sided) 95%
0.57 to 0.72
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ABC 600 mg / DTG 50 mg /3TC 300 mg FDC, Current ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.311
Comments Interleukin 6
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean ratio
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.93 to 1.24
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ABC 600 mg / DTG 50 mg /3TC 300 mg FDC, Current ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Soluble CD14
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean ratio
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.89 to 0.96
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ABC 600 mg / DTG 50 mg /3TC 300 mg FDC, Current ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.742
Comments Soluble vasc cell adhesion molecule 1
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean ratio
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.95 to 1.08
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Percent Change From Baseline in Cardiovascular Marker Analyte, C-reactive Protein at Week 24
Hide Description Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or African American, Other), and Baseline biomarker level.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only participants with a non-missing value at Week 24 are included.
Arm/Group Title ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Current ART
Hide Arm/Group Description:
Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Overall Number of Participants Analyzed 226 231
Geometric Mean (95% Confidence Interval)
Unit of Measure: Percent
1.25
(1.04 to 1.50)
1.25
(1.04 to 1.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC 600 mg / DTG 50 mg /3TC 300 mg FDC, Current ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.999
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.84 to 1.19
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Percent Change From Baseline in Cardiovascular Marker Analyte, D-Dimer at Week 24
Hide Description Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or African American, Other), and Baseline biomarker level.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only participants with a non-missing value at Week 24 are included.
Arm/Group Title ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Current ART
Hide Arm/Group Description:
Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Overall Number of Participants Analyzed 212 221
Geometric Mean (95% Confidence Interval)
Unit of Measure: Percent
1.00
(0.91 to 1.10)
1.00
(0.91 to 1.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC 600 mg / DTG 50 mg /3TC 300 mg FDC, Current ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.981
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.91 to 1.10
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Percent Change From Baseline in Cardiovascular Marker Analyte, Homostat Model Assess of Insulin Resistance at Week 24
Hide Description Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or african american, other), and Baseline biomarker level.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only participants with a non-missing value at Week 24 are included.
Arm/Group Title ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Current ART
Hide Arm/Group Description:
Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Overall Number of Participants Analyzed 210 219
Geometric Mean (95% Confidence Interval)
Unit of Measure: Percent
0.97
(0.84 to 1.11)
1.00
(0.87 to 1.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC 600 mg / DTG 50 mg /3TC 300 mg FDC, Current ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.640
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.85 to 1.11
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Percent Change From Baseline in Cardiovascular Marker Analyte, Insulin at Week 24
Hide Description Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or african american, other), and Baseline biomarker level.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only participants with a non-missing value at Week 24 are included.
Arm/Group Title ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Current ART
Hide Arm/Group Description:
Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Overall Number of Participants Analyzed 213 222
Geometric Mean (95% Confidence Interval)
Unit of Measure: Percent
0.97
(0.86 to 1.09)
0.99
(0.88 to 1.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC 600 mg / DTG 50 mg /3TC 300 mg FDC, Current ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.645
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.87 to 1.09
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Percent Change From Baseline in Cardiovascular Marker Analyte, Soluble CD163 at Week 24
Hide Description Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or african american, other), and Baseline biomarker level.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only participants with a non-missing value at Week 24 are included.
Arm/Group Title ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Current ART
Hide Arm/Group Description:
Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Overall Number of Participants Analyzed 213 222
Geometric Mean (95% Confidence Interval)
Unit of Measure: Percent
1.09
(1.04 to 1.15)
1.08
(1.02 to 1.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC 600 mg / DTG 50 mg /3TC 300 mg FDC, Current ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.577
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.97 to 1.06
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Percent Change From Baseline in Cardiovascular Marker Analyte, Glucose at Week 24
Hide Description Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or african american, other), and Baseline biomarker level.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only participants with a non-missing value at Week 24 are included.
Arm/Group Title ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Current ART
Hide Arm/Group Description:
Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Overall Number of Participants Analyzed 240 249
Geometric Mean (95% Confidence Interval)
Unit of Measure: Percent
1.02
(0.99 to 1.05)
1.01
(0.99 to 1.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC 600 mg / DTG 50 mg /3TC 300 mg FDC, Current ART
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.687
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.98 to 1.03
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Number of Participants With Incidence of Genotypic and Phenotypic Resistance Meeting Confirmed Virologic Withdrawal Criteria Over 24 Weeks
Hide Description Genotypic and phenotypic testing was conducted for participants who met the confirmed virologic withdrawal criteria, i.e., confirmed HIV-1 RNA >=400 c/mL any time after Day 1. The sample from the “suspected virologic withdrawal criterion” visit was tested for HIV-1 PRO and RT genotype and phenotype and HIV-1 integrase genotype and phenotype (i.e., the first of the two consecutive results >=400 c/mL). At the time of the data cut-off for this Week 24 analysis, no participants met the confirmed virologic withdrawal criteria over 24 weeks; therefore, the virologic analyses were not assessed.
Time Frame Baseline and up to 24 weeks
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Hide Analysis Population Description
Viral Genotypic and Phenotypic Populations: Comprised of all participants in the ITT-E Population with available on-treatment genotypic and phenotypic resistance data, respectively, at the time confirmed virologic withdrawal criterion was met.
Arm/Group Title ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Current ART
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Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Early Switch group AEs/SAEs are included from time of switch to ABC 600mg/DTG 50mg/3TC 300mg at baseline up to Week 48. Late Switch group AEs/SAEs are included from the time of switch to ABC 600mg/DTG 50mg/3TC 300mg at week 24 up to Week 48.
Adverse Event Reporting Description Adverse events (AEs) and serious adverse events (SAEs) are presented for the early Switch and Late Switch group. AEs and SAEs were collected from participants of the safety population, comprised of all participants who received atleast one dose of the study drug.
 
Arm/Group Title Early Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Late Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC
Hide Arm/Group Description Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks. Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
All-Cause Mortality
Early Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Late Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Early Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Late Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC
Affected / at Risk (%) Affected / at Risk (%)
Total   9/275 (3.27%)   6/244 (2.46%) 
Cardiac disorders     
Cardiac failure congestive  1  1/275 (0.36%)  0/244 (0.00%) 
Myocardial infarction  1  0/275 (0.00%)  1/244 (0.41%) 
Infections and infestations     
Cellulitis  1  1/275 (0.36%)  0/244 (0.00%) 
Diverticulitis  1  0/275 (0.00%)  1/244 (0.41%) 
Gastroenteritis  1  1/275 (0.36%)  0/244 (0.00%) 
Pneumonia bacterial  1  1/275 (0.36%)  0/244 (0.00%) 
Pyelonephritis  1  1/275 (0.36%)  0/244 (0.00%) 
Subcutaneous abscess  1  0/275 (0.00%)  1/244 (0.41%) 
Injury, poisoning and procedural complications     
Femur fracture  1  0/275 (0.00%)  1/244 (0.41%) 
Investigations     
Alanine aminotransferase increased  1  0/275 (0.00%)  1/244 (0.41%) 
Nervous system disorders     
Cerebrovascular accident  1  1/275 (0.36%)  0/244 (0.00%) 
Speech disorder  1  1/275 (0.36%)  0/244 (0.00%) 
Psychiatric disorders     
Suicide attempt  1  1/275 (0.36%)  0/244 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/275 (0.36%)  0/244 (0.00%) 
Pulmonary embolism  1  0/275 (0.00%)  1/244 (0.41%) 
Social circumstances     
Homicide  1  1/275 (0.36%)  0/244 (0.00%) 
Vascular disorders     
Hypertension  1  1/275 (0.36%)  0/244 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Early Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Late Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC
Affected / at Risk (%) Affected / at Risk (%)
Total   101/275 (36.73%)   61/244 (25.00%) 
Gastrointestinal disorders     
Diarrhoea  1  20/275 (7.27%)  9/244 (3.69%) 
Nausea  1  28/275 (10.18%)  15/244 (6.15%) 
General disorders     
Fatigue  1  22/275 (8.00%)  6/244 (2.46%) 
Infections and infestations     
Upper respiratory tract infection  1  35/275 (12.73%)  22/244 (9.02%) 
Nervous system disorders     
Headache  1  17/275 (6.18%)  10/244 (4.10%) 
Psychiatric disorders     
Insomnia  1  14/275 (5.09%)  9/244 (3.69%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  17/275 (6.18%)  6/244 (2.46%) 
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: NCT02105987     History of Changes
Obsolete Identifiers: NCT02131025
Other Study ID Numbers: 201147
First Submitted: April 3, 2014
First Posted: April 7, 2014
Results First Submitted: December 10, 2015
Results First Posted: February 25, 2016
Last Update Posted: January 4, 2017