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

March 10, 2025 updated by: Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: BETAF OD arm
one tablet taken orally once daily
Drug: Biktarvy 50 mg/200 mg/25 mg film-coated tablets
The duration of the study treatment will be 48 weeks.
Experimental: BETAF 3W arm
one tablet taken orally 3 days per week : Mondays, Wednesdays, and Fridays
Drug: Biktarvy 50 mg/200 mg/25 mg film-coated tablets
The duration of the study treatment will be 48 weeks.
Experimental: BETAF 2W arm
one tablet taken orally 2 days per week : Mondays, and Thursdays
Drug: Biktarvy 50 mg/200 mg/25 mg film-coated tablets
The duration of the study treatment will be 48 weeks.
Experimental: BETAF 1W arm
one tablet taken orally 1 days per week : Mondays
Drug: Biktarvy 50 mg/200 mg/25 mg film-coated tablets
The duration of the study treatment will be 48 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Viral efficacy of the reduction of BETAF regimen dose per week at 12 weeks.
Time Frame: 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.
Time Frame: at 48 weeks.
standard plasma viral load, lower limit of detection HIV RNA 50 copies/mL
at 48 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Virological efficacy assessed by Standard plasma viral load
Time Frame: at 4, 24, and 36 weeks.
-Standard plasma viral load, lower limit of detection HIV RNA 50 copies/mL)
at 4, 24, and 36 weeks.
Virological efficacy assessed by Blips (VL ≥50 copies/mL followed)
Time Frame: at 0, 4, 12, 24, 36, and 48 weeks
-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)
Time Frame: at 0, 4, 12, 24, 36, and 48 weeks
-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)
Time Frame: at 0, 12, and 48 weeks.
-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
Time Frame: at 0, 12, and 48 weeks.
- HIV-1 reservoir (total and integrated DNA) in CD4 cells
at 0, 12, and 48 weeks.
Virological efficacy assessed by ultra-deep sequencing of plasma and intracellular viral load to detect genotypic resistance
Time Frame: at 0, 4, 12, 24, 36 and 48 weeks
In case of virological failure, ultra-deep sequencing of plasma and intracellular viral load to detect genotypic resistance
at 0, 4, 12, 24, 36 and 48 weeks
Immunological safety assessed by CD4 and CD8 cells
Time Frame: at 0, 12 and 48 weeks
-CD4 and CD8 (cells/mL) will be combined to report CD4/CD8 ratio.
at 0, 12 and 48 weeks
Immunological safety 2 assessed by hsCRP, IL-6 and adiponectin levels
Time Frame: at 0, 12 and 48 weeks
-Inflammation (hsCRP, IL-6, adiponectin) (µg/mL), IL-6 (pg/mL), adiponectin (µg/mL) levels
at 0, 12 and 48 weeks
Immunological safety assessed by sCD14 and CD163 as a Immune activation markers
Time Frame: at 0, 12 and 48 weeks
- sCD14(ng/l ) and CD163 (ng/l) plasma levels
at 0, 12 and 48 weeks
Subclinical toxicity assessed by BMI index
Time Frame: at 4, 12, 24, 36, and 48
- Weight and body mass index (BMI)(kg/m2) changes
at 4, 12, 24, 36, and 48
Body composition assessed by DEXA scan
Time Frame: at 0 and 48 weeks
-Body composition (g/cm) (fat, fat-free mass, and bone by DEXA)
at 0 and 48 weeks
Impact on sleep quality assessed by Pittsburg Sleep Quality
Time Frame: at 0 and 48 weeks
- Impact on sleep quality will be evaluated througth Pittsburg Sleep Quality (visual analog score)questionaire at 0 and 48 weeks
at 0 and 48 weeks
Quality of life questionnaire assessed by EuroQol Group EQ-5D™ questionnaire
Time Frame: at 0 and 4,12,24,36, 48 weeks
- Impact on quality of life will be evaluated througth EuroQol Group EQ-5D™ (Units on a Scale)
at 0 and 4,12,24,36, 48 weeks
Minimum plasma concentration of bictegravir, emtricitabine and tenofovir (Cmim) assessed by Plasma levels of bictegravir, emtricitabine and tenofovir
Time Frame: at 0, 12, and 48 weeks
- Minimum plasma concentration of bictegravir, emtricitabine and tenofovir (Cmim) (μg/L)
at 0, 12, and 48 weeks
Minimum intracellular concentration of bictegravir, emtricitabine and tenofovir (Cmim)
Time Frame: at 0, 12, and 48 weeks
Minimum intracellular concentration of bictegravir, emtricitabine and tenofovir (Cmim) (μg/L)
at 0, 12, and 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundacion Clinic per a la Recerca Biomédica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BETAF-RED

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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