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

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

NCT05602506•Fundacion Clinic per a la Recerca Biomédica

View on ClinicalTrials.gov

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.

Detailed Description

The Primary objectives are: 1. To assess viral efficacy of the reductions of BETAF regimen dose at 12 weeks (on-treatment and intent-to-treat populations). 2. To asess viral efficacy of the reduction of BETAF regimen dose at 48 weeks (on-treatment and intent-to-treat populations).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Hospital Clinic i Provincial Barcelona

Barcelona, Spain

Key Dates

Start Date

November 15, 2022

Primary Completion Date

March 15, 2024

Completion Date

June 5, 2024

Last Updated

March 11, 2025

Enrollment

ACTUAL participants

Conditions

HIV Infections

Interventions

Biktarvy 50 mg/200 mg/25 mg film-coated tablets

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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