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Subjects do not receive study medication in this study 202094

Phase 3

HIV Infections | Small molecule | Infectious Disease |GSK plc|Last Updated: Oct 19, 2020

Success Probability

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment102

FDA Designations

No designations recorded

Clinical trial landscape

Subjects do not receive study medication in this study 202094 · 1 trial · 1 indication

Phase 3 1
NCT02478632Bone Mineral Density in Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Adult Subjects Switching From a Tenofovir Regimen to a Dolutegravir Plus Rilpivirine RegimenHIV Infections
COMPLETED102 Analytics
PHASE3COMPLETED
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
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 48
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 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.

Secondary Endpoints

Percent Change From Baseline in Lumbar Spine BMD at Week 48
Baseline (Day 1) and Week 48
Percent Change From Baseline in Total Hip and Lumbar Spine BMD-DTG+RPV Early Switch Group Through Early and Late Switch Phase
Baseline (Day 1), Week 48, Week 100 and Week 148
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
LS Baseline (Week 48), Week 100 and Week 148
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CARACTIVE_COMPARATORParticipants do not receive study medication in this study 202094. Participants group carried over from the parent study 201636 (SWORD-1) or 201637 (SWORD-2).
DTG 50 mg + RPV 25 mgEXPERIMENTALParticipants do not receive study medication in this study 202094. Participants group carried over from the parent study 201636 (SWORD-1) or 201637 (SWORD-2)

Interventions

NameTypeDescription
Subjects do not receive study medication in this study 202094DRUGParticipants do not receive study medication in this study 202094.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites32

Inclusion Criteria: * Screened and eligible but not yet randomised to either of the parent studies 201636 (SWORD-1) or 201637 (SWORD-2) * Receiving an ART regimen which contains TDF * Female subjects of child bearing potential with a negative pregnancy test at both Screening and Day 1 and agrees to...

Countries:United StatesArgentinaBelgiumCanadaSpainUnited Kingdom
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