INSTI's For The Management of HIV-associated TB

PHASE2CompletedINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

February 18, 2022

Primary Completion Date

January 19, 2024

Study Completion Date

August 31, 2024

Conditions
HIV/AIDSTuberculosis, Pulmonary
Interventions
COMBINATION_PRODUCT

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."

COMBINATION_PRODUCT

TLD- fixed-drug combination single tablet

Standard of care Dolutegravir-based regimen

Trial Locations (1)

4001

CAPRISA Springfield Clinical Research Site, Durban

All Listed Sponsors
collaborator

Johns Hopkins University

OTHER

collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

University of Cape Town

OTHER

collaborator

Medical Research Council, South Africa

OTHER

lead

Centre for the AIDS Programme of Research in South Africa

NETWORK