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Bone Mineral Density in Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Adult Subjects Switching From a Tenofovir Regimen to a Dolutegravir Plus Rilpivirine Regimen

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ClinicalTrials.gov Identifier: NCT02478632
Recruitment Status : Completed
First Posted : June 23, 2015
Results First Posted : October 20, 2017
Last Update Posted : March 17, 2020
Sponsor:
Collaborators:
Janssen Pharmaceuticals
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Intervention Drug: Subjects do not receive study medication in this study 202094
Enrollment 102
Recruitment Details Participants from early switch dolutegravir (DTG) plus rilpivirine (RPV) treatment groups and from late switch group who continue their current antiretroviral regimen (CAR) through Week 52 across both NCT02429791 and NCT02422797 were included in this sub-study 202094.
Pre-assignment Details Total 151 participants were screened, of which, 49 were screen failures and 102 were registered to study 202094. The study included an early switch phase and a late switch phase.
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the late switch phase in the parent study (study medication was administered in the parent study and not in study 202094). Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
Period Title: Early Switch Phase (Up to Week 52)
Started 53 49
Completed 49 44
Not Completed 4 5
Reason Not Completed
Withdrawal from parent study             4             5
Period Title: Late Switch Phase (Week 52 to Week 148)
Started 49 44
Completed 42 40
Not Completed 7 4
Reason Not Completed
Withdrawal from parent study             2             3
Prohibited medication use             5             1
Arm/Group Title DTG + RPV Current Antiretroviral Regimen Total
Hide Arm/Group Description Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the late switch phase in the parent study (study medication was administered in the parent study and not in study 202094). Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094). Total of all reporting groups
Overall Number of Baseline Participants 53 49 102
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 49 participants 102 participants
42.6  (10.80) 44.8  (10.66) 43.7  (10.73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 49 participants 102 participants
Female
27
  50.9%
26
  53.1%
53
  52.0%
Male
26
  49.1%
23
  46.9%
49
  48.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 49 participants 102 participants
American Indian/ Alaska native Heritage
4
   7.5%
1
   2.0%
5
   4.9%
Asian- Central/South Asian Heritage
0
   0.0%
1
   2.0%
1
   1.0%
Asian- Japanese/East Asian (EA)/ South EA heritage
2
   3.8%
0
   0.0%
2
   2.0%
Black / African American
3
   5.7%
7
  14.3%
10
   9.8%
White
44
  83.0%
40
  81.6%
84
  82.4%
1.Primary Outcome
Title Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 48
Hide Description Percent change in BMD (expressed as areal density in grams per centimeter square [g/cm^2]) as specified by dual energy X-ray absorptiometry (DEXA) scans of the left 'total hip' which included the femoral neck, trochanter and inter-trochanter areas was assessed by areal density at Baseline and Week 48. The estimated value in the statistical analysis is this difference and the upper and lower limit values shown are the 95% confidence intervals. Baseline was considered as Day 1 and percent change from Baseline was calculated as Value at Week 48 minus Baseline value divided by Baseline value multiplied by 100. An analysis of covariance (ANCOVA) model was used to compare the difference. The analysis was performed on Intent-to-Treat exposed DEXA (ITT-ED) Population which comprised of all participants in the ITT-E Population who received at least one dose of study treatment, and who were registered for the 202094 study.
Time Frame Baseline (Day 1) and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-ED Population. Only those participants with data available at specified time point were analyzed.
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the late switch phase in the parent study (study medication was administered in the parent study and not in study 202094).
Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
Overall Number of Participants Analyzed 46 35
Mean (95% Confidence Interval)
Unit of Measure: Percent change
1.34
(0.68 to 2.01)
0.05
(-0.71 to 0.82)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.29
Confidence Interval (2-Sided) 95%
0.27 to 2.31
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percent Change From Baseline in Lumbar Spine BMD at Week 48
Hide Description Percent change in BMD (expressed as areal density in g/cm^2) as specified by DEXA scans of the 'lumbar spine' which included the first lumbar vertebra (L1) to the fourth lumbar vertebra (L4) was assessed by areal density at Baseline and Week 48. The difference is adjusted percent change from Baseline to Week 48 between treatment groups. The estimated value in the statistical analysis is this difference and the upper and lower limit values shown are the 95% confidence intervals. Baseline was considered as Day 1 value and percent change from Baseline was calculated as Value at Week 48 minus Baseline value divided by Baseline value multiplied by 100. An ANCOVA model was used to compare the difference in percentage change from Baseline at week 48 in lumbar spine BMD between the DTG+RPV and CAR arms.
Time Frame Baseline (Day 1) and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-ED Population. Only those participants with data available at specified time point were analyzed.
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the late switch phase in the parent study (study medication was administered in the parent study and not in study 202094).
Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
Overall Number of Participants Analyzed 46 35
Mean (95% Confidence Interval)
Unit of Measure: Percent change
1.46
(0.65 to 2.28)
0.15
(-0.79 to 1.09)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.32
Confidence Interval (2-Sided) 95%
0.07 to 2.57
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percent Change From Baseline in Total Hip and Lumbar Spine BMD-DTG+RPV Early Switch Group Through Early and Late Switch Phase
Hide Description Percent change in BMD (expressed as areal density in g/cm^2) as specified by DEXA scans of left 'total hip' which included femoral neck, trochanter and inter-trochanter areas and 'lumbar spine' which included L1 to L4 was assessed by areal density. Percent change from Baseline is post-dose value minus Baseline value divided by Baseline value multiplied by 100. BMD parameters at Weeks 48, 100 and 148 reflect data adjusted following the ongoing longitudinal and cross-calibration of multiple DEXA scanner instruments in this study. Data presented through Week 48 only represent results of Week 48 Primary Endpoint analysis which applied DEXA scanner calibrations though Week 48, with no subsequent calibration applied. In the final analysis conducted at Week 148, DEXA scanner calibration data acquired from Day 1 to Week 148 was applied to all raw DEXA BMD data at Weeks 48, 100 and 148. Hence, actual values of Week 48 DEXA data may vary slightly between Weeks 48 and 148 analyses.
Time Frame Baseline (Day 1), Week 48, Week 100 and Week 148
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-ED Population. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.
Arm/Group Title DTG + RPV
Hide Arm/Group Description:
Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the late switch phase in the parent study (study medication was administered in the parent study and not in study 202094).
Overall Number of Participants Analyzed 53
Mean (95% Confidence Interval)
Unit of Measure: Percent change
Total hip; Week 48; n=46 Number Analyzed 46 participants
1.492
(0.74 to 2.24)
Total hip; Week 100; n=41 Number Analyzed 41 participants
1.081
(0.06 to 2.10)
Total hip; Week 148; n=40 Number Analyzed 40 participants
0.978
(-0.23 to 2.18)
Lumbar spine; Week 48; n=46 Number Analyzed 46 participants
1.648
(0.83 to 2.46)
Lumbar spine; Week 100; n=43 Number Analyzed 43 participants
0.810
(-0.39 to 2.01)
Lumbar spine; Week 148; n=42 Number Analyzed 42 participants
0.526
(-0.93 to 1.98)
4.Secondary Outcome
Title Percent Change From Late Switch (LS) Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD-CAR Late Switch Group Through Late Switch Phase
Hide Description Percent change in BMD (expressed as areal density in g/cm^2) as specified by DEXA scans of the left 'total hip' which included the femoral neck, trochanter and inter-trochanter areas was assessed by areal density at indicated time points. Percent change in BMD as specified by DEXA scans of the 'lumbar spine' which included the first lumbar vertebra (L1) to the fourth lumbar vertebra (L4) was assessed by areal density at indicated time points. The last pre-switch value (Week 48) was considered as LS Baseline and percent change from LS Baseline was calculated as post-dose visit value minus LS Baseline value divided by LS Baseline value multiplied by 100. The analysis was based on Late-Switch Intent-to-Treat Exposed DEXA (LS-ITT-ED) Population which comprised of all participants in the LS-ITT-E Population, and who were registered for the DEXA study.
Time Frame LS Baseline (Week 48), Week 100 and Week 148
Hide Outcome Measure Data
Hide Analysis Population Description
LS ITT-ED Population. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.
Arm/Group Title Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
Overall Number of Participants Analyzed 44
Mean (95% Confidence Interval)
Unit of Measure: Percent change
Total hip; Week 100; n=41 Number Analyzed 41 participants
1.107
(0.25 to 1.96)
Total hip; Week 148; n=40 Number Analyzed 40 participants
1.275
(0.39 to 2.16)
Lumbar spine; Week 100; n=41 Number Analyzed 41 participants
1.135
(0.11 to 2.16)
Lumbar spine; Week 148; n=40 Number Analyzed 40 participants
0.436
(-0.64 to 1.51)
5.Secondary Outcome
Title Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 Assessed by T-score and Z-score
Hide Description Total hip and lumbar spine BMD was assessed by T-scores and Z-scores. Day 1 was considered as Baseline. Change from Baseline was calculated as the value at Week 48 minus Baseline. DEXA scans of the left 'total hip' (femoral neck, hip, inter-trochanter areas, trochanter) and 'lumbar spine' (lumbar vertebral column) were performed. T-score is the number of standard deviations above or below the mean BMD of a 30-year-old participant of the same sex. Caucasian reference values were used for all participants to calculate T-scores. T-score values > -1.0 are considered normal, T-score values <= -1.0 to > -2.5 indicate osteopenia, T-score values <= -2.5 to <-3.5 indicate osteoporosis and T-score values <= -3.5 indicate severe osteoporosis. The Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex and in this study. Caucasian reference values were used in calculation of Z-scores.
Time Frame Baseline (Day 1) and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-ED Population. Only those participants with data available at specified time point were analyzed.
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the late switch phase in the parent study (study medication was administered in the parent study and not in study 202094).
Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
Overall Number of Participants Analyzed 46 35
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
Total hip; T-score
0.09
(0.05 to 0.14)
0.01
(-0.05 to 0.06)
Total hip; Z-score
0.11
(0.06 to 0.15)
0.02
(-0.03 to 0.08)
Lumbar spine; T-score
0.13
(0.05 to 0.20)
0.01
(-0.08 to 0.10)
Lumbar spine; Z-score
0.17
(0.09 to 0.25)
0.02
(-0.07 to 0.11)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments p value for the difference in adjusted change from Baseline at Week 48 in total hip T-scores between the DTG+RPV and CAR groups
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.09
Confidence Interval (2-Sided) 95%
0.02 to 0.16
Estimation Comments The analysis estimated the difference between DTG+RPV and CAR in total hip T-scores
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments p value for the difference in adjusted change from Baseline at Week 48 in total hip Z-scores between the DTG+RPV and CAR groups
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
0.01 to 0.15
Estimation Comments The analysis estimated difference between DTG+RPV and CAR in total hip Z-score.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments p value for the difference in adjusted change from Baseline at Week 48 in lumbar spine T-scores between the DTG+RPV and CAR groups
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
0.00 to 0.23
Estimation Comments The analysis estimated difference between DTG+RPV and CAR for lumbar spine T-score.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments p value for the difference in adjusted change from Baseline at Week 48 in lumbar spine Z-scores between the DTG+RPV and CAR groups
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.15
Confidence Interval (2-Sided) 95%
0.03 to 0.27
Estimation Comments The analysis estimated difference between DTG+RPV and CAR in lumbar spine Z-score.
6.Secondary Outcome
Title Change From Baseline in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores - DTG+RPV Early Switch Group Through Early and Late Switch Phase
Hide Description T-score is the number of standard deviations above or below the mean BMD of a 30-year-old participant of same sex. Caucasian reference values were used to calculate T- and Z- scores. T-score values: > -1.0 is normal; <= -1.0 to > -2.5 indicate osteopenia; <= -2.5 to <-3.5 indicate osteoporosis; <= -3.5 indicate severe osteoporosis. Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex in this study. Change from Baseline is post-dose visit value minus Baseline value. Data for Week 48 only represent final results of Week 48 Primary Endpoint analysis which applied DEXA scanner calibrations through Week 48, with no subsequent calibration applied. In the final analysis conducted at Week 148, DEXA scanner calibration data acquired from Day 1 to Week 148 was applied to all raw DEXA BMD data at Weeks 48, 100 and 148. Hence, actual values of Week 48 DEXA data may vary slightly between Weeks 48 and 148 analyses.
Time Frame Baseline (Day 1), Week 48, Week 100 and Week 148
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-ED Population. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.
Arm/Group Title DTG + RPV
Hide Arm/Group Description:
Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the late switch phase in the parent study (study medication was administered in the parent study and not in study 202094).
Overall Number of Participants Analyzed 53
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Total hip; T-score; Week 48; n=46 Number Analyzed 46 participants
0.101  (0.1681)
Total hip; T-score; Week 100; n=41 Number Analyzed 41 participants
0.066  (0.2248)
Total hip; T-score; Week 148; n=40 Number Analyzed 40 participants
0.062  (0.2600)
Total hip; Z-score; Week 48; n=46 Number Analyzed 46 participants
0.115  (0.1742)
Total hip; Z-score; Week 100; n=41 Number Analyzed 41 participants
0.107  (0.2222)
Total hip; Z-score; Week 148; n=40 Number Analyzed 40 participants
0.117  (0.2757)
Lumbar spine; T-score; Week 48; n=46 Number Analyzed 46 participants
0.139  (0.2511)
Lumbar spine; T-score; Week 100; n=43 Number Analyzed 43 participants
0.059  (0.3510)
Lumbar spine; T-score; Week 148; n=42 Number Analyzed 42 participants
0.034  (0.4183)
Lumbar spine; Z-score; Week 48; n=46 Number Analyzed 46 participants
0.182  (0.2563)
Lumbar spine; Z-score; Week 100; n=43 Number Analyzed 43 participants
0.142  (0.3868)
Lumbar spine; Z-score; Week 148; n=42 Number Analyzed 42 participants
0.139  (0.4507)
7.Secondary Outcome
Title Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores-CAR Late Switch Group Through Late Switch Phase
Hide Description The last pre-switch value (Week 48) was considered as LS Baseline and change from LS Baseline was calculated as the post-dose visit value minus LS Baseline value. DEXA scans of the left 'total hip' (femoral neck, hip, inter-trochanter areas, trochanter) and 'lumbar spine' (lumbar vertebral column) were performed. T-score is the number of standard deviations above or below the mean BMD of a 30-year-old participant of the same sex. Caucasian reference values were used for all participants to calculate T-scores. T-score values > -1.0 are considered normal, T-score values <= -1.0 to > -2.5 indicate osteopenia, T-score values <= -2.5 to <-3.5 indicate osteoporosis and T-score values <= -3.5 indicate severe osteoporosis. The Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex and in this study. Caucasian reference values were used in calculation of Z-scores.
Time Frame LS Baseline (Week 48), Week 100, Week 148
Hide Outcome Measure Data
Hide Analysis Population Description
LS ITT-ED Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Arm/Group Title Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
Overall Number of Participants Analyzed 44
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Total hip; T-score; Week 100; n=41 Number Analyzed 41 participants
0.080  (0.1957)
Total hip; T-score; Week 148; n=40 Number Analyzed 40 participants
0.091  (0.1995)
Total hip; Z-score; Week 100; n=41 Number Analyzed 41 participants
0.107  (0.2055)
Total hip; Z-score; Week 148; n=40 Number Analyzed 40 participants
0.125  (0.2117)
Lumbar spine; T-score; Week 100; n=41 Number Analyzed 41 participants
0.111  (0.2914)
Lumbar spine; T-score; Week 148; n=40 Number Analyzed 40 participants
0.049  (0.3204)
Lumbar spine; Z-score; Week 100; n=41 Number Analyzed 41 participants
0.176  (0.2598)
Lumbar spine; Z-score; Week 148; n=40 Number Analyzed 40 participants
0.127  (0.3392)
8.Secondary Outcome
Title Percent Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 by Baseline Third Agent
Hide Description Total hip and lumbar spine BMD (expressed as areal density in g/cm^2) assessed by third agent class (INSTI, NNRTI, PI) at indicated time points. Percent change from Baseline was calculated as value at Week 48 minus Baseline value divided by Baseline value multiplied by 100. Value at Day 1 was considered as Baseline. An ANCOVA model adjusted for Baseline BMD values was used to compare the difference in percent change from Baseline to Week 48 in total hip BMD or in lumbar spine BMD between the DTG+RPV and CAR arms by third agent class: INSTI, NNRTI or PI.
Time Frame Baseline (Day 1) and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-ED Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the late switch phase in the parent study (study medication was administered in the parent study and not in study 202094).
Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
Overall Number of Participants Analyzed 46 35
Mean (95% Confidence Interval)
Unit of Measure: Percent change
Total hip; INSTI; n=7, 4 Number Analyzed 7 participants 4 participants
2.03
(-0.47 to 4.53)
1.38
(-1.93 to 4.69)
Total hip; NNRTI; n=28, 24 Number Analyzed 28 participants 24 participants
1.33
(0.51 to 2.16)
-0.27
(-1.16 to 0.62)
Total hip; PI; n=11, 7 Number Analyzed 11 participants 7 participants
1.11
(-0.34 to 2.56)
0.12
(-1.72 to 1.95)
Lumbar spine; INSTI; n=7, 3 Number Analyzed 7 participants 3 participants
1.43
(-0.31 to 3.17)
-2.42
(-5.08 to 0.24)
Lumbar spine; NNRTI; n=28, 26 Number Analyzed 28 participants 26 participants
1.38
(0.34 to 2.42)
0.12
(-0.96 to 1.20)
Lumbar spine; PI; n=11, 6 Number Analyzed 11 participants 6 participants
1.78
(-0.22 to 3.78)
1.40
(-1.32 to 4.11)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.65
Confidence Interval (2-Sided) 95%
-3.51 to 4.81
Estimation Comments The analysis refers to INSTI and total hip.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.60
Confidence Interval (2-Sided) 95%
0.39 to 2.81
Estimation Comments The analysis refers to NNRTI and total hip.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
-1.39 to 3.38
Estimation Comments this analysis refers to PI and total hip
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.85
Confidence Interval (2-Sided) 95%
0.67 to 7.03
Estimation Comments this analysis refers to INSTI and lumbar spine.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.25
Confidence Interval (2-Sided) 95%
-0.26 to 2.76
Estimation Comments this analysis refers to NNRTI and lumbar spine
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.38
Confidence Interval (2-Sided) 95%
-3.00 to 3.77
Estimation Comments this analysis refers to PI and lumbar spine
9.Secondary Outcome
Title Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent
Hide Description Total hip and lumbar spine BMD was assessed by Baseline third agent class (INSTI, NNRTI, PI) using T-scores and Z-scores at Baseline and Week 48. DEXA scans of hip and spine were performed. Value at Day 1 was considered as Baseline. Change from Baseline was calculated as the value at Week 48 minus Baseline value. T-score is the number of standard deviations above or below the mean BMD of a 30-year-old participant of the same sex. Caucasian reference values were used for all participants to calculate T-scores. T-score values > -1.0 are considered normal, T-score values <= -1.0 to > -2.5 indicate osteopenia, T-score values <= -2.5 to <-3.5 indicate osteoporosis and T-score values <= -3.5 indicate severe osteoporosis. The Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex and in this study. Caucasian reference values were used in calculation of Z-scores.
Time Frame Baseline (Day 1) and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-ED Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Arm/Group Title DTG + RPV Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the late switch phase in the parent study (study medication was administered in the parent study and not in study 202094).
Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
Overall Number of Participants Analyzed 46 35
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
Total hip; T-score; INSTI; n=7, 4 Number Analyzed 7 participants 4 participants
0.13
(-0.04 to 0.29)
0.11
(-0.11 to 0.33)
Total hip; T-score; NNRTI; n=28, 24 Number Analyzed 28 participants 24 participants
0.09
(0.04 to 0.15)
-0.02
(-0.08 to 0.04)
Total hip; T-score; PI; n=11, 7 Number Analyzed 11 participants 7 participants
0.08
(-0.02 to 0.18)
0.01
(-0.12 to 0.13)
Total hip; Z-score; INSTI; n=7, 4 Number Analyzed 7 participants 4 participants
0.18
(-0.00 to 0.36)
0.12
(-0.13 to 0.36)
Total hip; Z-score; NNRTI; n=28, 24 Number Analyzed 28 participants 24 participants
0.10
(0.04 to 0.16)
0.00
(-0.06 to 0.06)
Total hip; Z-score; PI; n=11, 7 Number Analyzed 11 participants 7 participants
0.08
(-0.02 to 0.19)
0.05
(-0.08 to 0.18)
Lumbar spine; T-score; INSTI; n=7, 3 Number Analyzed 7 participants 3 participants
0.14
(-0.04 to 0.33)
-0.22
(-0.51 to 0.07)
Lumbar spine; T-score; NNRTI; n=28, 26 Number Analyzed 28 participants 26 participants
0.11
(0.02 to 0.21)
0.00
(-0.10 to 0.10)
Lumbar spine; T-score; PI; n=11, 6 Number Analyzed 11 participants 6 participants
0.15
(-0.03 to 0.34)
0.14
(-0.11 to 0.39)
Lumbar spine; Z-score; INSTI; n=7, 3 Number Analyzed 7 participants 3 participants
0.19
(0.01 to 0.38)
-0.19
(-0.48 to 0.10)
Lumbar spine; Z-score; NNRTI; n=28, 26 Number Analyzed 28 participants 26 participants
0.13
(0.04 to 0.23)
0.01
(-0.09 to 0.11)
Lumbar spine; Z-score; PI; n=11,6 Number Analyzed 11 participants 6 participants
0.24
(0.06 to 0.41)
0.19
(-0.05 to 0.43)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.26 to 0.30
Estimation Comments The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip T-scores by baseline third agent INSTI.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
0.03 to 0.19
Estimation Comments The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip T-scores by baseline third agent NNRTI.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
-0.09 to 0.24
Estimation Comments The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip T-scores by baseline third agent PI.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.25 to 0.37
Estimation Comments The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip Z-scores by baseline third agent INSTI.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
0.02 to 0.18
Estimation Comments The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip Z-scores by baseline third agent NNRTI.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.14 to 0.21
Estimation Comments The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip Z-scores by baseline third agent PI.
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.36
Confidence Interval (2-Sided) 95%
0.01 to 0.71
Estimation Comments The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine T-scores by baseline third agent INSTI.
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
-0.03 to 0.25
Estimation Comments The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine T-scores by baseline third agent NNRTI.
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.30 to 0.33
Estimation Comments The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine T-scores by baseline third agent PI.
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.38
Confidence Interval (2-Sided) 95%
0.03 to 0.74
Estimation Comments The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine Z-scores by baseline third agent INSTI.
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
-0.02 to 0.26
Estimation Comments The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine Z-scores by baseline third agent NNRTI.
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection DTG + RPV, Current Antiretroviral Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.26 to 0.34
Estimation Comments The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine Z-scores by baseline third agent PI.
10.Secondary Outcome
Title Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase
Hide Description Total hip and lumbar spine BMD (expressed as areal density in g/cm^2) assessed by third agent class (INSTI, NNRTI, PI) at indicated time points. Percent change from Baseline was calculated as post-dose value minus Baseline value divided by Baseline value multiplied by 100. BMD parameters expressed as areal density (g/cm^2) at Weeks 48, 100 and 148 reflect data adjusted following the ongoing longitudinal and cross-calibration of the multiple DEXA scanner instruments in this study. Data and analyses presented through Week 48 only represent the final results of Week 48 Primary Endpoint analysis which applied DEXA scanner calibrations though Week 48, with no subsequent calibration applied. In the final analysis conducted at Week 148, DEXA scanner calibration data acquired from Day 1 to Week 148 was applied to all raw DEXA BMD data at Weeks 48, 100 and 148. Hence, the actual values of Week 48 DEXA data may vary slightly between the Week 48 and Week 148 analyses.
Time Frame Baseline (Day 1), Week 48, Week 100 and Week 148
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-ED Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Arm/Group Title DTG + RPV
Hide Arm/Group Description:
Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the late switch phase in the parent study (study medication was administered in the parent study and not in study 202094).
Overall Number of Participants Analyzed 53
Mean (Standard Deviation)
Unit of Measure: Percent change
Total hip; INSTI; Week 48; n=7 Number Analyzed 7 participants
1.918  (3.3468)
Total hip; INSTI; Week 100; n=6 Number Analyzed 6 participants
1.165  (4.5857)
Total hip; INSTI; Week 148; n=6 Number Analyzed 6 participants
1.738  (3.1881)
Total hip; NNRTI; Week 48; n=28 Number Analyzed 28 participants
1.422  (2.4137)
Total hip; NNRTI; Week 100; n=25 Number Analyzed 25 participants
0.722  (2.6977)
Total hip; NNRTI; Week 148; n=24 Number Analyzed 24 participants
0.524  (4.0553)
Total hip; PI; Week 48; n=11 Number Analyzed 11 participants
1.401  (2.4406)
Total hip; PI; Week 100; n=10 Number Analyzed 10 participants
1.927  (3.7412)
Total hip; PI; Week 148; n=10 Number Analyzed 10 participants
1.610  (3.5534)
Lumbar spine; INSTI; Week 48; n=7 Number Analyzed 7 participants
1.439  (2.2786)
Lumbar spine; INSTI; Week 100; n=6 Number Analyzed 6 participants
0.779  (2.6627)
Lumbar spine; INSTI; Week 148; n=6 Number Analyzed 6 participants
-0.306  (0.8815)
Lumbar spine; NNRTI; Week 48; n=28 Number Analyzed 28 participants
1.570  (2.9752)
Lumbar spine; NNRTI; Week 100; n=26 Number Analyzed 26 participants
-0.025  (3.9606)
Lumbar spine; NNRTI; Week 148; n=25 Number Analyzed 25 participants
0.067  (5.4222)
Lumbar spine; PI; Week 48; n=11 Number Analyzed 11 participants
1.977  (2.5587)
Lumbar spine; PI; Week 100; n=11 Number Analyzed 11 participants
2.801  (3.8743)
Lumbar spine; PI; Week 148; n=11 Number Analyzed 11 participants
2.026  (3.8869)
11.Secondary Outcome
Title Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase
Hide Description T-score is the number of standard deviations above or below the mean BMD of a 30-year-old participant of same sex. Caucasian reference values were used to calculate T- and Z-scores. T-score values > -1.0 is normal; <= -1.0 to > -2.5 indicate osteopenia; <= -2.5 to <-3.5 indicate osteoporosis; <= -3.5 indicate severe osteoporosis. Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex in this study. Change from Baseline is the post-dose value minus Baseline value. Data for Week 48 only represents final results of Week 48 Primary Endpoint analysis which applied DEXA scanner calibrations through 48, with no subsequent calibration applied. In the final analysis conducted at Week 148, DEXA scanner calibration data acquired from Day 1 to Week 148 was applied to all raw DEXA BMD data at Weeks 48, 100 and 148. Hence, actual values of Week 48 DEXA data may vary slightly between Weeks 48 and 148 analyses.
Time Frame Baseline (Day 1), Week 48, Week 100 and Week 148
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-ED Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Arm/Group Title DTG + RPV
Hide Arm/Group Description:
Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the late switch phase in the parent study (study medication was administered in the parent study and not in study 202094).
Overall Number of Participants Analyzed 53
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
INSTI; Total hip; T-score; Week 48; n=7 Number Analyzed 7 participants
0.119  (0.2171)
INSTI; Total hip; T-score; Week 100; n=6 Number Analyzed 6 participants
0.069  (0.2854)
INSTI; Total hip; T-score; Week 148; n=6 Number Analyzed 6 participants
0.116  (0.2057)
INSTI; Total hip; Z-score; Week 48; n=7 Number Analyzed 7 participants
0.162  (0.2402)
INSTI; Total hip; Z-score; Week 100; n=6 Number Analyzed 6 participants
0.161  (0.2912)
INSTI; Total hip; Z-score; Week 148; n=6 Number Analyzed 6 participants
0.219  (0.2360)
INSTI; Lumbar spine; T-score; Week 48; n=7 Number Analyzed 7 participants
0.141  (0.2212)
INSTI; Lumbar spine; T-score; Week 100; n=6 Number Analyzed 6 participants
0.087  (0.2611)
INSTI; Lumbar spine; T-score; Week 148; n=6 Number Analyzed 6 participants
-0.026  (0.0826)
INSTI; Lumbar spine; Z-score; Week 48; n=7 Number Analyzed 7 participants
0.196  (0.2100)
INSTI; Lumbar spine; Z-score; Week 100; n=6 Number Analyzed 6 participants
0.267  (0.3905)
INSTI; Lumbar spine; Z-score; Week 148; n=6 Number Analyzed 6 participants
0.191  (0.2644)
NNRTI; Total hip; T-score; Week 48; n=28 Number Analyzed 28 participants
0.098  (0.1593)
NNRTI; Total hip; T-score; Week 100; n=25 Number Analyzed 25 participants
0.045  (0.1938)
NNRTI; Total hip; T-score; Week 148; n=24 Number Analyzed 24 participants
0.028  (0.2786)
NNRTI; Total hip; Z-score; Week 48; n=28 Number Analyzed 28 participants
0.107  (0.1574)
NNRTI; Total hip; Z-score; Week 100; n=25 Number Analyzed 25 participants
0.077  (0.1856)
NNRTI; Total hip; Z-score; Week 148; n=24 Number Analyzed 24 participants
0.071  (0.2958)
NNRTI; Lumbar spine; T-score; Week 48; n=28 Number Analyzed 28 participants
0.126  (0.2687)
NNRTI; Lumbar spine; T-score; Week 100; n=26 Number Analyzed 26 participants
-0.022  (0.3558)
NNRTI; Lumbar spine; T-score; Week 148; n=25 Number Analyzed 25 participants
-0.015  (0.4802)
NNRTI; Lumbar spine; Z-score; Week 48; n=28 Number Analyzed 28 participants
0.150  (0.2669)
NNRTI; Lumbar spine; Z-score; Week 100; n=26 Number Analyzed 26 participants
0.021  (0.3539)
NNRTI; Lumbar spine; Z-score; Week 148; n=25 Number Analyzed 25 participants
0.049  (0.5248)
PI; Total hip; T-Score; Week 48; n=11 Number Analyzed 11 participants
0.097  (0.1731)
PI; Total hip; T-Score; Week 100; n=10 Number Analyzed 10 participants
0.118  (0.2740)
PI; Total hip; T-Score; Week 148; n=10 Number Analyzed 10 participants
0.110  (0.2521)
PI; Total hip; Z-Score; Week 48; n=11 Number Analyzed 11 participants
0.106  (0.1823)
PI; Total hip; Z-Score; Week 100; n=10 Number Analyzed 10 participants
0.150  (0.2722)
PI; Total hip; Z-Score; Week 148 ;n=10 Number Analyzed 10 participants
0.166  (0.2441)
PI; Lumbar spine; T-Score; Week 48 ;n=11 Number Analyzed 11 participants
0.172  (0.2406)
PI; Lumbar spine; T-Score; Week 100 ;n=11 Number Analyzed 11 participants
0.235  (0.3396)
PI; Lumbar spine; T-Score; Week 148 ;n=11 Number Analyzed 11 participants
0.179  (0.3599)
PI; Lumbar spine; Z-Score; Week 48 ;n=11 Number Analyzed 11 participants
0.257  (0.2601)
PI; Lumbar spine; Z-Score; Week 100 ;n=11 Number Analyzed 11 participants
0.360  (0.3732)
PI; Lumbar spine; Z-Score; Week 148 ;n=11 Number Analyzed 11 participants
0.317  (0.2828)
12.Secondary Outcome
Title Percent Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase
Hide Description Total hip and lumbar spine BMD (expressed as areal density in g/cm^2) assessed by third agent class (INSTI, NNRTI, PI) at indicated time points. The last pre-switch value (Week 48) was considered as LS Baseline and percent change from LS Baseline was calculated as post-dose value minus LS Baseline value divided by LS Baseline value multiplied by 100.
Time Frame LS Baseline (Week 48), Week 100 and Week 148
Hide Outcome Measure Data
Hide Analysis Population Description
LS ITT-ED Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Arm/Group Title Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
Overall Number of Participants Analyzed 44
Mean (Standard Deviation)
Unit of Measure: Percent change
Total hip; INSTI; Week 100; n=3 Number Analyzed 3 participants
2.298  (2.7510)
Total hip; INSTI; Week 148; n=3 Number Analyzed 3 participants
2.405  (1.8787)
Total hip; NNRTI; Week 100; n=29 Number Analyzed 29 participants
1.049  (2.9845)
Total hip; NNRTI; Week 148; n=29 Number Analyzed 29 participants
1.498  (2.8487)
Total hip; PI; Week 100; n=9 Number Analyzed 9 participants
0.898  (1.7838)
Total hip; PI; Week 148; n=8 Number Analyzed 8 participants
0.042  (2.5640)
Lumbar Spine; INSTI; Week 100; n=3 Number Analyzed 3 participants
2.195  (1.1188)
Lumbar Spine; INSTI; Week 148; n=3 Number Analyzed 3 participants
1.121  (1.3711)
Lumbar Spine; NNRTI; Week 100; n=29 Number Analyzed 29 participants
1.017  (2.7142)
Lumbar Spine; NNRTI; Week 148; n=29 Number Analyzed 29 participants
0.335  (3.5996)
Lumbar Spine; PI; Week 100; n=9 Number Analyzed 9 participants
1.160  (5.1050)
Lumbar Spine; PI; Week 148; n=8 Number Analyzed 8 participants
0.546  (3.1654)
13.Secondary Outcome
Title Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase
Hide Description Total hip and lumbar spine BMD was assessed by Baseline third agent (INSTI, NNRTI, PI) using T-scores and Z-scores at indicated time points. DEXA scans of hip and spine were performed. The last pre-switch value (Week 48) was considered as LS Baseline and change from LS Baseline was calculated as the post-dose value minus LS Baseline value. T-score is the number of standard deviations above or below the mean BMD of a 30-year-old participant of the same sex. Caucasian reference values were used for all participants to calculate T-scores. T-score values > -1.0 are considered normal, T-score values <= -1.0 to > -2.5 indicate osteopenia, T-score values <= -2.5 to <-3.5 indicate osteoporosis and T-score values <= -3.5 indicate severe osteoporosis. The Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex and in this study. Caucasian reference values were used in calculation of Z-scores.
Time Frame LS Baseline (Week 48), Week 100 and Week 148
Hide Outcome Measure Data
Hide Analysis Population Description
LS ITT-ED Population.Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Arm/Group Title Current Antiretroviral Regimen
Hide Arm/Group Description:
Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
Overall Number of Participants Analyzed 44
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
INSTI; Hip; T-score; Week 100; n=3 Number Analyzed 3 participants
0.166  (0.1971)
INSTI; Hip; T-score; Week 148; n=3 Number Analyzed 3 participants
0.173  (0.1333)
INSTI; Hip; Z-score; Week 100; n=3 Number Analyzed 3 participants
0.167  (0.1623)
INSTI; Hip; Z-score; Week 148; n=3 Number Analyzed 3 participants
0.197  (0.0800)
INSTI; Spine; T-score; Week 100; n=3 Number Analyzed 3 participants
0.201  (0.1102)
INSTI; Spine; T-score; Week 148; n=3 Number Analyzed 3 participants
0.099  (0.1164)
INSTI; Spine; Z-score; Week 100; n=3 Number Analyzed 3 participants
0.247  (0.0376)
INSTI; Spine; Z-score; Week 148; n=3 Number Analyzed 3 participants
0.145  (0.1888)
NNRTI; Hip; T-score; Week 100; n=29 Number Analyzed 29 participants
0.075  (0.2149)
NNRTI; Hip; T-score; Week 148; n=29 Number Analyzed 29 participants
0.106  (0.2064)
NNRTI; Hip; Z-score; Week 100; n=29 Number Analyzed 29 participants
0.101  (0.2261)
NNRTI; Hip; Z-score; Week 148; n=29 Number Analyzed 29 participants
0.136  (0.2213)
NNRTI; Spine; T-score; Week 100; n=29 Number Analyzed 29 participants
0.103  (0.2630)
NNRTI; Spine; T-score; Week 148; n=29 Number Analyzed 29 participants
0.045  (0.3441)
NNRTI; Spine; Z-score; Week 100; n=29 Number Analyzed 29 participants
0.164  (0.2711)
NNRTI; Spine; Z-score; Week 148; n=29 Number Analyzed 29 participants
0.124  (0.3482)
PI; Hip; T-Score; Week 100; n=9 Number Analyzed 9 participants
0.069  (0.1309)
PI; Hip; T-Score; Week 148; n=8 Number Analyzed 8 participants
0.007  (0.1856)
PI; Hip; Z-Score; Week 100; n=9 Number Analyzed 9 participants
0.107  (0.1558)
PI; Hip; Z-Score; Week 148 ;n=8 Number Analyzed 8 participants
0.061  (0.2111)
PI; Spine; T-Score; Week 100 ;n=9 Number Analyzed 9 participants
0.105  (0.4198)
PI; Spine; T-Score; Week 148 ;n=8 Number Analyzed 8 participants
0.044  (0.3052)
PI; Spine; Z-Score; Week 100 ;n=9 Number Analyzed 9 participants
0.191  (0.2776)
PI; Spine; Z-Score; Week 148 ;n=8 Number Analyzed 8 participants
0.133  (0.3817)
Time Frame On-treatment SAEs and non-serious AEs were collected from the start of the study treatment up to 148 weeks.
Adverse Event Reporting Description AEs were reported for the Safety DEXA Population defined as participants in the parent Safety Populations who participated in the DEXA study. Only AEs considered related to the DEXA study procedure were collected in this study. All other AEs will be public disclosed for the parent studies (201636 [NCT02429791] and 201637 [NCT02422797]). Through the 148 weeks of conduct, no AEs considered related to the DEXA study procedure were reported. No deaths were reported for 202094 study participants.
 
Arm/Group Title DTG + RPV (Early Switch) CAR (Early Switch) DTG + RPV (Early + Late Switch) CAR (Late Switch)
Hide Arm/Group Description Participants received DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study. Study medication was administered in the parent study (201636 [NCT02429791] and 201637 [NCT02422797]) and not in study 202094. Participants continued to receive their CAR (two NRTIs + a third agent). A third agent included either: an INSTI, a NNRTI or a PI. CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. Study medication was administered in the parent study (201636 [NCT02429791] and 201637 [NCT02422797]) and not in study 202094. Participants received DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the Late Switch Phase in the parent study. Study medication was administered in the parent study (201636 [NCT02429791] and 201637 [NCT02422797]) and not in study 202094. At Week 52, participants who received CAR during the early switch phase, with HIV-1 RNA <50 c/mL, switched to DTG + RPV once daily and were followed until Week 148 in the parent study. Study medication was administered in the parent study (201636 [NCT02429791] and 201637 [NCT02422797]) and not in study 202094.
All-Cause Mortality
DTG + RPV (Early Switch) CAR (Early Switch) DTG + RPV (Early + Late Switch) CAR (Late Switch)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/53 (0.00%)   0/49 (0.00%)   0/53 (0.00%)   0/44 (0.00%) 
Hide Serious Adverse Events
DTG + RPV (Early Switch) CAR (Early Switch) DTG + RPV (Early + Late Switch) CAR (Late Switch)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/53 (0.00%)   0/49 (0.00%)   0/53 (0.00%)   0/44 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DTG + RPV (Early Switch) CAR (Early Switch) DTG + RPV (Early + Late Switch) CAR (Late Switch)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/53 (0.00%)   0/49 (0.00%)   0/53 (0.00%)   0/44 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: ViiV Healthcare
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Layout table for additonal information
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT02478632    
Other Study ID Numbers: 202094
First Submitted: May 28, 2015
First Posted: June 23, 2015
Results First Submitted: July 27, 2017
Results First Posted: October 20, 2017
Last Update Posted: March 17, 2020