drugset / Trial / NCT05602506

Safety, Tolerability, and Efficacy of a Dose Reduction Strategy Based on Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-infected Adults

NCT05602506

Phase 4 Completed 40 enrolled Fundacion Clinic per a la Recerca Biomédica
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a phase IV, unicentric, open, pilot, randomized, controlled trial to evaluate Bictegravir/FTC/TAF. The study will be developed at a single clinical care centre:Hospital Clínic de Barcelona, Barcelona, Spain. The aim of this study is to assess the feasibility of dose redutions of Bictegravir/FTC/TAF in virologically suppressed HIV-infected adults on BETAF once daily. The reduction of drug exposure will have a significant positive impact on parameters reflecting potential toxicities associated with bictegravir or tenofovir.

Timeline

Start
2022-11-15
Primary completion
2024-03-15
Completion
2024-06-05

Drugs

EvaluationDrugModalityDoseRoute
Subject bictegravir Small molecule Oral