Clinical trial NCT05602506: Safety, Tolerability, and Efficacy of a Dose Reduction Strategy Based on Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-infected Adults
Official title: Safety, Tolerability, and Efficacy of a Dose Reduction Strategy Based on Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-infected Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Viral efficacy of the reduction of BETAF regimen dose per week at 12 weeks.
timeFrame: at 12 weeks
measure: Viral efficacy of the reduction of BETAF regimen dose per week at 48 weeks.
timeFrame: at 48 weeks.
Secondary outcomes:
measure: Virological efficacy assessed by Standard plasma viral load
timeFrame: at 4, 24, and 36 weeks.
measure: Virological efficacy assessed by Blips (VL ≥50 copies/mL followed)
timeFrame: at 0, 4, 12, 24, 36, and 48 weeks
measure: Virological efficacy assessed by Target not detected with standard plasma viral load (VL ≥ HIV RNA 50 copies/mL)
timeFrame: at 0, 4, 12, 24, 36, and 48 weeks
measure: Virological efficacy assessed by Ultrasensitive plasma viral load (lower limit of detection 5 copies/mL)
timeFrame: at 0, 12, and 48 weeks.
measure: Virological efficacy assessed by HIV-1 reservoir (total and integrated DNA (copies/106 PBMC)) in CD4 cells
timeFrame: at 0, 12, and 48 weeks.
measure: Virological efficacy assessed by ultra-deep sequencing of plasma and intracellular viral load to detect genotypic resistance
timeFrame: at 0, 4, 12, 24, 36 and 48 weeks
measure: Immunological safety assessed by CD4 and CD8 cells
timeFrame: at 0, 12 and 48 weeks
measure: Immunological safety 2 assessed by hsCRP, IL-6 and adiponectin levels
timeFrame: at 0, 12 and 48 weeks
measure: Immunological safety assessed by sCD14 and CD163 as a Immune activation markers
timeFrame: at 0, 12 and 48 weeks
measure: Subclinical toxicity assessed by BMI index
timeFrame: at 4, 12, 24, 36, and 48
measure: Body composition assessed by DEXA scan
timeFrame: at 0 and 48 weeks
measure: Impact on sleep quality assessed by Pittsburg Sleep Quality
timeFrame: at 0 and 48 weeks
measure: Quality of life questionnaire assessed by EuroQol Group EQ-5D™ questionnaire
timeFrame: at 0 and 4,12,24,36, 48 weeks
measure: Minimum plasma concentration of bictegravir, emtricitabine and tenofovir (Cmim) assessed by Plasma levels of bictegravir, emtricitabine and tenofovir
timeFrame: at 0, 12, and 48 weeks
measure: Minimum intracellular concentration of bictegravir, emtricitabine and tenofovir (Cmim)
timeFrame: at 0, 12, and 48 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial Barcelona
Study officials:
References: