Who is sponsoring NCT02478632?

NCT02478632 is sponsored by ViiV Healthcare.

What drugs are being tested in NCT02478632?

Interventions in NCT02478632: Subjects do not receive study medication in this study 202094.

What condition does NCT02478632 study?

NCT02478632 studies HIV Infections.

Is NCT02478632 still recruiting?

NCT02478632 is currently completed. Last updated 19 October 2020.

Are results published for NCT02478632?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-10-19 · How we verify

NCT02478632

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 19 October 2020

What this trial tests

Phase 3 trial testing Subjects do not receive study medication in this study 202094 in HIV Infections in 102 participants. Completed in 17 August 2018.

Timeline

12 June 2015

Primary endpoint
16 September 2016

17 August 2018

Quick facts

Lead sponsor	ViiV Healthcare
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	102
Start date	12 June 2015
Primary completion	16 September 2016
Estimated completion	17 August 2018
Sites	32 locations across Belgium, United Kingdom, Argentina, Canada, United States, Spain

Drugs / interventions tested

Subjects do not receive study medication in this study 202094 — full drug profile →

Conditions studied

HIV Infections — all drugs for HIV Infections →

Sponsor

ViiV Healthcare — full company profile →

Who can join

18 and older, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 48 Primary · Baseline (Day 1) and Week 48

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 mu

Group	Value	95% CI
DTG + RPV	1.34	0.68 – 2.01
Current Antiretroviral Regimen	0.05	-0.71 – 0.82

Percent Change From Baseline in Lumbar Spine BMD at Week 48 Secondary · Baseline (Day 1) and Week 48

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 Bas

Group	Value	95% CI
DTG + RPV	1.46	0.65 – 2.28
Current Antiretroviral Regimen	0.15	-0.79 – 1.09

Percent Change From Baseline in Total Hip and Lumbar Spine BMD-DTG+RPV Early Switch Group Through Early and Late Switch Phase Secondary · Baseline (Day 1), Week 48, Week 100 and Week 148

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

Total hip; Week 48; n=46

Group	Value	95% CI
DTG + RPV	1.492	0.74 – 2.24

Total hip; Week 100; n=41

Group	Value	95% CI
DTG + RPV	1.081	0.06 – 2.10

Total hip; Week 148; n=40

Group	Value	95% CI
DTG + RPV	0.978	-0.23 – 2.18

Lumbar spine; Week 48; n=46

Group	Value	95% CI
DTG + RPV	1.648	0.83 – 2.46

Lumbar spine; Week 100; n=43

Group	Value	95% CI
DTG + RPV	0.810	-0.39 – 2.01

Lumbar spine; Week 148; n=42

Group	Value	95% CI
DTG + RPV	0.526	-0.93 – 1.98

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 Secondary · LS Baseline (Week 48), Week 100 and Week 148

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 B

Total hip; Week 100; n=41

Group	Value	95% CI
Current Antiretroviral Regimen	1.107	0.25 – 1.96

Total hip; Week 148; n=40

Group	Value	95% CI
Current Antiretroviral Regimen	1.275	0.39 – 2.16

Lumbar spine; Week 100; n=41

Group	Value	95% CI
Current Antiretroviral Regimen	1.135	0.11 – 2.16

Lumbar spine; Week 148; n=40

Group	Value	95% CI
Current Antiretroviral Regimen	0.436	-0.64 – 1.51

Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 Assessed by T-score and Z-score Secondary · Baseline (Day 1) and Week 48

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.

Total hip; T-score

Group	Value	95% CI
DTG + RPV	0.09	0.05 – 0.14
Current Antiretroviral Regimen	0.01	-0.05 – 0.06

Total hip; Z-score

Group	Value	95% CI
DTG + RPV	0.11	0.06 – 0.15
Current Antiretroviral Regimen	0.02	-0.03 – 0.08

Lumbar spine; T-score

Group	Value	95% CI
DTG + RPV	0.13	0.05 – 0.20
Current Antiretroviral Regimen	0.01	-0.08 – 0.10

Lumbar spine; Z-score

Group	Value	95% CI
DTG + RPV	0.17	0.09 – 0.25
Current Antiretroviral Regimen	0.02	-0.07 – 0.11

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 Secondary · Baseline (Day 1), Week 48, Week 100 and Week 148

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

Total hip; T-score; Week 48; n=46

Group	Value	95% CI
DTG + RPV	0.101	± 0.1681

Total hip; T-score; Week 100; n=41

Group	Value	95% CI
DTG + RPV	0.066	± 0.2248

Total hip; T-score; Week 148; n=40

Group	Value	95% CI
DTG + RPV	0.062	± 0.2600

Total hip; Z-score; Week 48; n=46

Group	Value	95% CI
DTG + RPV	0.115	± 0.1742

Total hip; Z-score; Week 100; n=41

Group	Value	95% CI
DTG + RPV	0.107	± 0.2222

Total hip; Z-score; Week 148; n=40

Group	Value	95% CI
DTG + RPV	0.117	± 0.2757

Lumbar spine; T-score; Week 48; n=46

Group	Value	95% CI
DTG + RPV	0.139	± 0.2511

Lumbar spine; T-score; Week 100; n=43

Group	Value	95% CI
DTG + RPV	0.059	± 0.3510

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 Secondary · LS Baseline (Week 48), Week 100, Week 148

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 indi

Total hip; T-score; Week 100; n=41

Group	Value	95% CI
Current Antiretroviral Regimen	0.080	± 0.1957

Total hip; T-score; Week 148; n=40

Group	Value	95% CI
Current Antiretroviral Regimen	0.091	± 0.1995

Total hip; Z-score; Week 100; n=41

Group	Value	95% CI
Current Antiretroviral Regimen	0.107	± 0.2055

Total hip; Z-score; Week 148; n=40

Group	Value	95% CI
Current Antiretroviral Regimen	0.125	± 0.2117

Lumbar spine; T-score; Week 100; n=41

Group	Value	95% CI
Current Antiretroviral Regimen	0.111	± 0.2914

Lumbar spine; T-score; Week 148; n=40

Group	Value	95% CI
Current Antiretroviral Regimen	0.049	± 0.3204

Lumbar spine; Z-score; Week 100; n=41

Group	Value	95% CI
Current Antiretroviral Regimen	0.176	± 0.2598

Lumbar spine; Z-score; Week 148; n=40

Group	Value	95% CI
Current Antiretroviral Regimen	0.127	± 0.3392

Percent Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 by Baseline Third Agent Secondary · Baseline (Day 1) and Week 48

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.

Total hip; INSTI; n=7, 4

Group	Value	95% CI
DTG + RPV	2.03	-0.47 – 4.53
Current Antiretroviral Regimen	1.38	-1.93 – 4.69

Total hip; NNRTI; n=28, 24

Group	Value	95% CI
DTG + RPV	1.33	0.51 – 2.16
Current Antiretroviral Regimen	-0.27	-1.16 – 0.62

Total hip; PI; n=11, 7

Group	Value	95% CI
DTG + RPV	1.11	-0.34 – 2.56
Current Antiretroviral Regimen	0.12	-1.72 – 1.95

Lumbar spine; INSTI; n=7, 3

Group	Value	95% CI
DTG + RPV	1.43	-0.31 – 3.17
Current Antiretroviral Regimen	-2.42	-5.08 – 0.24

Lumbar spine; NNRTI; n=28, 26

Group	Value	95% CI
DTG + RPV	1.38	0.34 – 2.42
Current Antiretroviral Regimen	0.12	-0.96 – 1.20

Lumbar spine; PI; n=11, 6

Group	Value	95% CI
DTG + RPV	1.78	-0.22 – 3.78
Current Antiretroviral Regimen	1.40	-1.32 – 4.11

Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent Secondary · Baseline (Day 1) and Week 48

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 indi

Total hip; T-score; INSTI; n=7, 4

Group	Value	95% CI
DTG + RPV	0.13	-0.04 – 0.29
Current Antiretroviral Regimen	0.11	-0.11 – 0.33

Total hip; T-score; NNRTI; n=28, 24

Group	Value	95% CI
DTG + RPV	0.09	0.04 – 0.15
Current Antiretroviral Regimen	-0.02	-0.08 – 0.04

Total hip; T-score; PI; n=11, 7

Group	Value	95% CI
DTG + RPV	0.08	-0.02 – 0.18
Current Antiretroviral Regimen	0.01	-0.12 – 0.13

Total hip; Z-score; INSTI; n=7, 4

Group	Value	95% CI
DTG + RPV	0.18	-0.00 – 0.36
Current Antiretroviral Regimen	0.12	-0.13 – 0.36

Total hip; Z-score; NNRTI; n=28, 24

Group	Value	95% CI
DTG + RPV	0.10	0.04 – 0.16
Current Antiretroviral Regimen	0.00	-0.06 – 0.06

Total hip; Z-score; PI; n=11, 7

Group	Value	95% CI
DTG + RPV	0.08	-0.02 – 0.19
Current Antiretroviral Regimen	0.05	-0.08 – 0.18

Lumbar spine; T-score; INSTI; n=7, 3

Group	Value	95% CI
DTG + RPV	0.14	-0.04 – 0.33
Current Antiretroviral Regimen	-0.22	-0.51 – 0.07

Lumbar spine; T-score; NNRTI; n=28, 26

Group	Value	95% CI
DTG + RPV	0.11	0.02 – 0.21
Current Antiretroviral Regimen	0.00	-0.10 – 0.10

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 Secondary · Baseline (Day 1), Week 48, Week 100 and Week 148

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

Total hip; INSTI; Week 48; n=7

Group	Value	95% CI
DTG + RPV	1.918	± 3.3468

Total hip; INSTI; Week 100; n=6

Group	Value	95% CI
DTG + RPV	1.165	± 4.5857

Total hip; INSTI; Week 148; n=6

Group	Value	95% CI
DTG + RPV	1.738	± 3.1881

Total hip; NNRTI; Week 48; n=28

Group	Value	95% CI
DTG + RPV	1.422	± 2.4137

Total hip; NNRTI; Week 100; n=25

Group	Value	95% CI
DTG + RPV	0.722	± 2.6977

Total hip; NNRTI; Week 148; n=24

Group	Value	95% CI
DTG + RPV	0.524	± 4.0553

Total hip; PI; Week 48; n=11

Group	Value	95% CI
DTG + RPV	1.401	± 2.4406

Total hip; PI; Week 100; n=10

Group	Value	95% CI
DTG + RPV	1.927	± 3.7412

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 Secondary · Baseline (Day 1), Week 48, Week 100 and Week 148

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 Pri

INSTI; Total hip; T-score; Week 48; n=7

Group	Value	95% CI
DTG + RPV	0.119	± 0.2171

INSTI; Total hip; T-score; Week 100; n=6

Group	Value	95% CI
DTG + RPV	0.069	± 0.2854

INSTI; Total hip; T-score; Week 148; n=6

Group	Value	95% CI
DTG + RPV	0.116	± 0.2057

INSTI; Total hip; Z-score; Week 48; n=7

Group	Value	95% CI
DTG + RPV	0.162	± 0.2402

INSTI; Total hip; Z-score; Week 100; n=6

Group	Value	95% CI
DTG + RPV	0.161	± 0.2912

INSTI; Total hip; Z-score; Week 148; n=6

Group	Value	95% CI
DTG + RPV	0.219	± 0.2360

INSTI; Lumbar spine; T-score; Week 48; n=7

Group	Value	95% CI
DTG + RPV	0.141	± 0.2212

INSTI; Lumbar spine; T-score; Week 100; n=6

Group	Value	95% CI
DTG + RPV	0.087	± 0.2611

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 Secondary · LS Baseline (Week 48), Week 100 and Week 148

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.

Total hip; INSTI; Week 100; n=3

Group	Value	95% CI
Current Antiretroviral Regimen	2.298	± 2.7510

Total hip; INSTI; Week 148; n=3

Group	Value	95% CI
Current Antiretroviral Regimen	2.405	± 1.8787

Total hip; NNRTI; Week 100; n=29

Group	Value	95% CI
Current Antiretroviral Regimen	1.049	± 2.9845

Total hip; NNRTI; Week 148; n=29

Group	Value	95% CI
Current Antiretroviral Regimen	1.498	± 2.8487

Total hip; PI; Week 100; n=9

Group	Value	95% CI
Current Antiretroviral Regimen	0.898	± 1.7838

Total hip; PI; Week 148; n=8

Group	Value	95% CI
Current Antiretroviral Regimen	0.042	± 2.5640

Lumbar Spine; INSTI; Week 100; n=3

Group	Value	95% CI
Current Antiretroviral Regimen	2.195	± 1.1188

Lumbar Spine; INSTI; Week 148; n=3

Group	Value	95% CI
Current Antiretroviral Regimen	1.121	± 1.3711

Sponsor's own description

The purpose of this study is to evaluate any change from baseline in bone mineral density (BMD) in subjects following the switch from a triple antiretroviral therapy (ART) regimen containing Tenofovir disoproxil fumarate (TDF) to the nucleoside reverse transcriptase inhibitor (NRTI) - sparing two - drug regimen of dolutegravir (DTG) + rilpivirine (RPV) in subjects participating in the parent studies 201636 and 201637 (SWORD-1 and SWORD-2). This open-label, parallel group, study is a sub-study which will recruit subjects who are receiving ART regimens which include TDF at the time of randomization to receive treatment in one of two identical parent studies 201636 and 201637 (SWORD-1 and SWORD-2). These are Phase III, randomised, open-label, multicentre, parallel-group, non-inferiority studies evaluating the efficacy, safety, and tolerability of switching to DTG plus RPV from current integrase inhibitor (INI)-, non NNRTI-, or protease inhibitor (PI)-based antiretroviral regimen in HIV-1-infected adults who are virologically suppressed, having HIV-1 ribonucleic acid (RNA) levels \<50 copies per millilitre (c/mL). Randomisation in the parent studies will be stratified by baseline third agent class (INI, NNRTI, or PI), age group (\< or =\>50 years old) and participation in this Dual energy X-ray absorptiometry (DEXA) sub-study, therefore there will also be balance across the treatment arms in this sub-study both overall and with respect to baseline third agent class and age at entry. The study population will include approximately 75 evaluable subjects recruited from the Early Switch DTG + RPV treatment group of the parent studies 201636 and 201637, and approximately 75 evaluable subjects from the Late Switch group who continue their current antiretroviral therapy (CAR) through to Week 52 across both the 201636 and 201637 (SWORD-1 and SWORD-2) studies. Subjects participating in study 202094 will have DEXA scans performed at Day 1 and at study Weeks 48, 100 and 148 in parallel with the corresponding scheduled visits in the parent studies.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Switch from tenofovir disoproxil fumarate combination to dolutegravir with rilpivirine improves parameters of bone health.
McComsey GA, Lupo S, Parks D, Poggio MC, et al · · 2018 · cited 38× · PMID 29239893 · DOI 10.1097/qad.0000000000001725

Verify or expand the search:

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Other ViiV Healthcare trials

Trials by the same sponsor.

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NCT07275606 — A Study to Investigate Cabotegravir for Neonates Exposed to HIV-1 · Phase 1, PHASE2 · not yet recruiting
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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02478632 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by ViiV Healthcare
Last refreshed: 19 October 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02478632.

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