drugset / Trial / NCT03656783
Effects of Biktarvy on CFR in Stable HIV Patients
Phase 3
Completed
25 enrolled
Brigham and Women's Hospital
Boston Medical Center · collabTufts Medical Center · collab
NaSingle-groupOpen-labelTreatment
Summary
Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is a single pill regimen that was approved by the FDA in February 2018 for treatment of HIV. The marketed name of the drug is Biktarvy. In two phase 3 comparative clinical trials, including one with ABC/3TC/DTG, it was found to be non-inferior to dolutegravir-containing regimens in terms of virologic outcomes. B/F/TAF was also well tolerated, with few discontinuations for adverse events. As a result, B/F/TAF is an ideal non-abacavir containing regimen to assess the effect of removing ABC on coronary flow reserve.
Timeline
- Start
- 2018-09-14
- Primary completion
- 2021-09-15
- Completion
- 2021-09-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Biktarvy | Other / unclassified | — | — |