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

NCT05602506 | Completed Phase 4

• 1 other identifier: BETAF-RED
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (2)

• Viral efficacy of the reduction of BETAF regimen dose per week at 12 weeks.

  standard plasma viral load, lower limit of detection HIV RNA 50 copies/mL

  at 12 weeks

• Viral efficacy of the reduction of BETAF regimen dose per week at 48 weeks.

  standard plasma viral load, lower limit of detection HIV RNA 50 copies/mL

  at 48 weeks.

Secondary Outcomes (15)

• Virological efficacy assessed by Standard plasma viral load

  at 4, 24, and 36 weeks.

• Virological efficacy assessed by Blips (VL ≥50 copies/mL followed)

  at 0, 4, 12, 24, 36, and 48 weeks

• Virological efficacy assessed by Target not detected with standard plasma viral load (VL ≥ HIV RNA 50 copies/mL)

  at 0, 4, 12, 24, 36, and 48 weeks

• Virological efficacy assessed by Ultrasensitive plasma viral load (lower limit of detection 5 copies/mL)

  at 0, 12, and 48 weeks.

• Virological efficacy assessed by HIV-1 reservoir (total and integrated DNA (copies/106 PBMC)) in CD4 cells

  at 0, 12, and 48 weeks.

Study Arms (4)

BETAF OD arm

ACTIVE COMPARATOR

one tablet taken orally once daily

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

BETAF 3W arm

EXPERIMENTAL

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

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

BETAF 2W arm

EXPERIMENTAL

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

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

BETAF 1W arm

EXPERIMENTAL

one tablet taken orally 1 days per week : Mondays

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

Interventions

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

The duration of the study treatment will be 48 weeks.

BETAF 1W arm; BETAF 2W arm; BETAF 3W arm; BETAF OD arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients agreed to participate.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion Clinic per a la Recerca Biomédica: lead

Study Sites (1)

Hospital Clinic i Provincial Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

HIV Infections

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: November 2, 2022
• Study Start: November 15, 2022
• Primary Completion: March 15, 2024
• Study Completion: June 5, 2024
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)