Overview

Effects of Biktarvy on CFR in Stable HIV Patients

Status:
Active, not recruiting
Trial end date:
2021-11-30
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Brigham and Women's Hospital
Collaborators:
Boston Medical Center
Tufts Medical Center
Treatments:
Emtricitabine
Emtricitabine tenofovir alafenamide
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Tenofovir