Efficacy, Tolerability and Acceptability of Biktarvy by TPLWH
Summary
This is a clinical trial for TPLWH (Trans People Living with HIV) who are stable on cART with an undetectable viral load or a detectable viral load but no resistance to NRTIs and InSTI. Following written consent and screening procedures, study subjects will undergo a switch (or will restart) of their combination antiretroviral therapy (cART) to Biktarvy. The goal of this research project is to recruit an understudied population into a controlled clinical trial aimed at optimizing TPLWH cART. This will be demonstrated by measuring viral load outcomes at regular intervals, with a focus on viral load results 48 weeks after Biktarvy initiation (primary outcome).
Timeline
- Start
- 2023-01-07
- Primary completion
- 2023-05-11
- Completion
- 2023-05-11
Outcome
Outcome not reported
Stopped (Business): “Trial set up was delayed, funding support no longer available”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bictegravir | Small molecule | 50 mg | — |
| Subject | emtricitabine | Other / unclassified | 200 mg | — |
| Subject | tenofovir alafenamide | Small molecule | 25 mg | — |