122
Participants
Start Date
February 18, 2022
Primary Completion Date
January 19, 2024
Study Completion Date
August 31, 2024
Biktarvy®
"Biktarvy® is a fixed dose combination, single tablet containing bictegravir (BIC), emtricitabine (FTC), and tenofovir alafenamide (TAF) for oral administration.~BIC is an integrase strand transfer inhibitor (INSTI). FTC, a synthetic nucleoside analog of cytidine, is an HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI). TAF, an HIV NRTI, is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Each tablet contains 50 mg of BIC (equivalent to 52.5 mg of bictegravir sodium), 200 mg of FTC, and 25 mg of TAF (equivalent to 28 mg of tenofovir alafenamide fumarate) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose."
TLD- fixed-drug combination single tablet
Standard of care Dolutegravir-based regimen
CAPRISA Springfield Clinical Research Site, Durban
Johns Hopkins University
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
University of Cape Town
OTHER
Medical Research Council, South Africa
OTHER
Centre for the AIDS Programme of Research in South Africa
NETWORK