Testing the Safety and Efficacy of Commercial Drug Biktarvy in Subjects Known to Have the 184 Resistance Mutation to a Component in Biktarvy

Summary

An Open-Label Study to Evaluate Switching from a Regimen of Elvitegravir/Tenofovir alafenamide/Emtricitabine/Cobicistat and Darunavir, to a Fixed-Dose Combination of Bictegravir/Tenofovir alafenamide/Emtricitabine in Virologically Suppressed HIV-1 Subjects who are known to have a I84 V/I Mutation

Timeline

Start

2019-07-01

Primary completion

2022-06-14

Completion

2022-07-08

Outcome

Outcome not reported

Stopped (Enrollment): “Unable to complete enrollment goals due to unanticipated factors of screen failures, covid pandemic, and continued staffing and enrollment difficulties”

Drugs

Indications