Safety, Tolerability, and Efficacy of a Dose Reduction Strategy Based on Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-infected Adults
- Conditions
- HIV Infections
- Interventions
- Registration Number
- NCT05602506
- Lead Sponsor
- Fundacion Clinic per a la Recerca Biomédica
- 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BETAF OD arm Biktarvy 50 mg/200 mg/25 mg film-coated tablets one tablet taken orally once daily BETAF 2W arm Biktarvy 50 mg/200 mg/25 mg film-coated tablets one tablet taken orally 2 days per week : Mondays, and Thursdays BETAF 1W arm Biktarvy 50 mg/200 mg/25 mg film-coated tablets one tablet taken orally 1 days per week : Mondays BETAF 3W arm Biktarvy 50 mg/200 mg/25 mg film-coated tablets one tablet taken orally 3 days per week : Mondays, Wednesdays, and Fridays
- Primary Outcome Measures
Name Time Method Viral efficacy of the reduction of BETAF regimen dose per week at 12 weeks. at 12 weeks standard plasma viral load, lower limit of detection HIV RNA 50 copies/mL
Viral efficacy of the reduction of BETAF regimen dose per week at 48 weeks. at 48 weeks. standard plasma viral load, lower limit of detection HIV RNA 50 copies/mL
- Secondary Outcome Measures
Name Time Method Immunological safety assessed by CD4 and CD8 cells at 0, 12 and 48 weeks -CD4 and CD8 (cells/mL) will be combined to report CD4/CD8 ratio.
Minimum plasma concentration of bictegravir, emtricitabine and tenofovir (Cmim) assessed by Plasma levels of bictegravir, emtricitabine and tenofovir at 0, 12, and 48 weeks - Minimum plasma concentration of bictegravir, emtricitabine and tenofovir (Cmim) (μg/L)
Virological efficacy assessed by Standard plasma viral load at 4, 24, and 36 weeks. -Standard plasma viral load, lower limit of detection HIV RNA 50 copies/mL)
Virological efficacy assessed by Blips (VL ≥50 copies/mL followed) at 0, 4, 12, 24, 36, and 48 weeks -Blips (VL ≥50 copies/mL followed)
Virological efficacy assessed by HIV-1 reservoir (total and integrated DNA (copies/106 PBMC)) in CD4 cells at 0, 12, and 48 weeks. - HIV-1 reservoir (total and integrated DNA) in CD4 cells
Immunological safety 2 assessed by hsCRP, IL-6 and adiponectin levels at 0, 12 and 48 weeks -Inflammation (hsCRP, IL-6, adiponectin) (µg/mL), IL-6 (pg/mL), adiponectin (µg/mL) levels
Quality of life questionnaire assessed by EuroQol Group EQ-5D™ questionnaire 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)
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 -Target not detected with standard plasma viral load (VL ≥ HIV RNA 50 copies/mL)
Impact on sleep quality assessed by Pittsburg Sleep Quality 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
Virological efficacy assessed by Ultrasensitive plasma viral load (lower limit of detection 5 copies/mL) at 0, 12, and 48 weeks. -Ultrasensitive plasma viral load (lower limit of detection 5 copies/mL)
Virological efficacy assessed by ultra-deep sequencing of plasma and intracellular viral load to detect genotypic resistance 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
Immunological safety assessed by sCD14 and CD163 as a Immune activation markers at 0, 12 and 48 weeks - sCD14(ng/l ) and CD163 (ng/l) plasma levels
Subclinical toxicity assessed by BMI index at 4, 12, 24, 36, and 48 - Weight and body mass index (BMI)(kg/m2) changes
Body composition assessed by DEXA scan at 0 and 48 weeks -Body composition (g/cm) (fat, fat-free mass, and bone by DEXA)
Minimum intracellular concentration of bictegravir, emtricitabine and tenofovir (Cmim) at 0, 12, and 48 weeks Minimum intracellular concentration of bictegravir, emtricitabine and tenofovir (Cmim) (μg/L)
Trial Locations
- Locations (1)
Hospital Clinic i Provincial Barcelona
🇪🇸Barcelona, Spain