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

HIV Infections Clinical Trial

— BETAF-RED  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05602506
• Other study ID #: BETAF-RED
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: November 15, 2022
• Est. completion date: July 3, 2025

Study information

• Verified date: September 2023
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: July 3, 2025
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Biktarvy 50 mg/200 mg/25 mg film-coated tablets
The duration of the study treatment will be 48 weeks.

Locations

Country	Name	City	State
Spain	Hospital Clinic i Provincial Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Clinic per a la Recerca Biomédica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Virological efficacy assessed by Standard plasma viral load	-Standard plasma viral load, lower limit of detection HIV RNA 50 copies/mL)	at 4, 24, and 36 weeks.
Secondary	Virological efficacy assessed by Blips (VL =50 copies/mL followed)	-Blips (VL =50 copies/mL followed)	at 0, 4, 12, 24, 36, and 48 weeks
Secondary	Virological efficacy assessed by Target not detected with standard plasma viral load (VL = HIV RNA 50 copies/mL)	-Target not detected with standard plasma viral load (VL = HIV RNA 50 copies/mL)	at 0, 4, 12, 24, 36, and 48 weeks
Secondary	Virological efficacy assessed by Ultrasensitive plasma viral load (lower limit of detection 5 copies/mL)	-Ultrasensitive plasma viral load (lower limit of detection 5 copies/mL)	at 0, 12, and 48 weeks.
Secondary	Virological efficacy assessed by HIV-1 reservoir (total and integrated DNA (copies/106 PBMC)) in CD4 cells	- HIV-1 reservoir (total and integrated DNA) in CD4 cells	at 0, 12, and 48 weeks.
Secondary	Virological efficacy assessed by ultra-deep sequencing of plasma and intracellular viral load to detect genotypic resistance	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
Secondary	Immunological safety assessed by CD4 and CD8 cells	-CD4 and CD8 (cells/mL) will be combined to report CD4/CD8 ratio.	at 0, 12 and 48 weeks
Secondary	Immunological safety 2 assessed by hsCRP, IL-6 and adiponectin levels	-Inflammation (hsCRP, IL-6, adiponectin) (µg/mL), IL-6 (pg/mL), adiponectin (µg/mL) levels	at 0, 12 and 48 weeks
Secondary	Immunological safety assessed by sCD14 and CD163 as a Immune activation markers	- sCD14(ng/l ) and CD163 (ng/l) plasma levels	at 0, 12 and 48 weeks
Secondary	Subclinical toxicity assessed by BMI index	- Weight and body mass index (BMI)(kg/m2) changes	at 4, 12, 24, 36, and 48
Secondary	Body composition assessed by DEXA scan	-Body composition (g/cm) (fat, fat-free mass, and bone by DEXA)	at 0 and 48 weeks
Secondary	Impact on sleep quality assessed by Pittsburg Sleep Quality	- 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
Secondary	Quality of life questionnaire assessed by EuroQol Group EQ-5D™ questionnaire	- 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
Secondary	Minimum plasma concentration of bictegravir, emtricitabine and tenofovir (Cmim) assessed by Plasma levels of bictegravir, emtricitabine and tenofovir	- Minimum plasma concentration of bictegravir, emtricitabine and tenofovir (Cmim) (µg/L)	at 0, 12, and 48 weeks
Secondary	Minimum intracellular concentration of bictegravir, emtricitabine and tenofovir (Cmim)	Minimum intracellular concentration of bictegravir, emtricitabine and tenofovir (Cmim) (µg/L)	at 0, 12, and 48 weeks