Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Subjects do not receive study medication in this study 202094 · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| CAR | ACTIVE_COMPARATOR | Participants 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 mg | EXPERIMENTAL | Participants do not receive study medication in this study 202094. Participants group carried over from the parent study 201636 (SWORD-1) or 201637 (SWORD-2) |
| Name | Type | Description |
|---|---|---|
| Subjects do not receive study medication in this study 202094 | DRUG | Participants do not receive study medication in this study 202094. |
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...
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| Pfizer Inc. | PFE | 7 | PHASE3 | VLA15, Prevenar 20, 13vPnC, ATM-AVI, PG4 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE3 | PCV21 |
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| Hoffmann-La Roche | RHHBY | 1 | PHASE3 | Baloxavir Marboxil |
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| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
| Tarsus Pharmaceuticals, Inc. | TARS | 1 | PHASE2 | TP-05 |
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Study 202094 is a completed Phase 3 trial conducted by GSK plc that examined bone mineral density in HIV-1 infected adults who switched from a tenofovir-containing regimen to a dolutegravir plus rilpivirine regimen. The trial enrolled 102 participants across the United States, Argentina, Belgium, Canada, Spain, and the United Kingdom.
GSK plc, which trades under the ticker GSK, is the developer of study 202094. The trial was conducted as a Phase 3 study in adult subjects with HIV-1 infection and has been completed.
Study 202094 is a completed Phase 3 trial. It enrolled 102 adult participants with HIV-1 infection and evaluated bone mineral density outcomes in subjects switching from a tenofovir regimen to a dolutegravir plus rilpivirine regimen. The study is no longer active.
Study 202094 corresponds to clinical trial NCT02478632, titled 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. The Phase 3 trial enrolled 102 participants, was active-controlled, and has been completed.
Study 202094 investigated bone mineral density in HIV-1 infected adults who switched from a tenofovir-containing regimen to a dolutegravir plus rilpivirine regimen. It was an active-controlled Phase 3 trial in 102 participants aged 18 years and older, conducted across six countries.