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

• Status: Not yet recruiting
• Trial end date: 2023-10-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion Clinic per a la Recerca Biomédica

Criteria

Inclusion Criteria:

• Stable and asymptomatic HIV-infected adults (≥18 years) on BETAF once daily for at least the previous 6 months.

• Plasma HIV-1 RNA less than 50 copies/mL for at least the previous 6 months.

• CD4 cell counts greater than 350 cells/mL at the time of consideration for the study.

• Women of child-bearing potential must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods.

• Patients agreed to participate.

Exclusion Criteria:

• Prior virological failure to any antiretroviral regimen or documented.

• Any diagnosis of psychiatric illness.

• Alcohol abuse or illicit drug consumption (based on their past medical history and specific questions at the time of recruitment).

• Patients co-infected with HIV and active hepatitis B or C virus.

• Any other condition at the doctor's discretion that did not allow ensuring a correct adherence.