drugset / Trial / NCT03916328
BONE: STAR (Switching to TAF Based Anti-Retroviral Therapy) Study
RandomizedParallel-groupOpen-labelTreatment
Summary
The primarily objective of this study is to assess the effect of switching from Tenofovir Disoproxil Fumurate (TDF) to TAF based ART on bone mass and turnover among women on DMPA for contraception. HIV virologically suppressed women on DMPA will be switched from their TDF based regimen to Bictergravir /Emtricitabine / Tenofovir alafenamide (B/F/TAF; Biktarvy®) in a randomized fashion. HIV infected women on TDF and non-hormonal contraception will be switched to Biktarvy®).
Timeline
- Start
- 2019-12-03
- Primary completion
- 2024-03-31
- Completion
- 2024-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | B/F/TAF | Unknown | — | — |
| Comparator | Tenofovir Disoproxil Fumurate | Unknown | — | — |
| Comparator | DTG | Unknown | — | — |
| Comparator | EFV | Unknown | — | — |
| Comparator | Lamivudine | Other / unclassified | — | — |
| Comparator | NVP | Unknown | — | — |