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

Fundacion Clinic per a la Recerca Biomédica

Status and phase: Completed; Phase 4

Conditions: HIV Infections

Treatments: Drug: Biktarvy 50 mg/200 mg/25 mg film-coated tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT05602506

BETAF-RED

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

BETAF OD arm

Active Comparator group

Description:

one tablet taken orally once daily

Treatment:

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

BETAF 3W arm

Experimental group

Description:

one tablet taken orally 3 days per week : Mondays, Wednesdays, and Fridays

Treatment:

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

BETAF 2W arm

Experimental group

Description:

one tablet taken orally 2 days per week : Mondays, and Thursdays

Treatment:

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

BETAF 1W arm

Experimental group

Description:

one tablet taken orally 1 days per week : Mondays

Treatment:

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