Skip to main content
OpenTrials
Completed

NCT Number: NCT05602506

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clinic i Provincial Barcelona

Barcelona, 08036, Spain

About this study

The Primary objectives are:

  • To assess viral efficacy of the reductions of BETAF regimen dose at 12 weeks (on-treatment and intent-to-treat populations).
  • To asess viral efficacy of the reduction of BETAF regimen dose at 48 weeks (on-treatment and intent-to-treat populations).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

The duration of the study treatment will be 48 weeks.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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

  6. 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

  7. 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.

  8. 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

  9. 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

  10. Subclinical toxicity assessed by BMI index

    Time frame: at 4, 12, 24, 36, and 48

    • Weight and body mass index (BMI)(kg/m2) changes

  11. 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)

  12. 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

  13. 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)

  14. 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)

  15. 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)

Sponsors and collaborators

Lead sponsor

Fundacion Clinic per a la Recerca Biomédica

Other

Registry information

Acronym: BETAF-RED

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 2, 2022
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.