A Study to Determine the Cartography of Virologic Reservoir Related to Antiretroviral Concentrations in HIV-1 Chronic Patients Treated by a First Line Treatment Containing bictégravir, Emtricitabine and ténofovir alafénamide

NCT05222945 · tracked via the Priya Life Science France tracker

Sponsor

ANRS, Emerging Infectious Diseases

Phase

Not applicable

Started

2025-04-01

Last updated

2025-02-05

Condition(s) studied

HIV-1-infection

Investigational drug(s) / intervention(s)

Biopsies and bloood samplings

Biopsies and bloood samplings: blood samples, rectal biopsies, nodes biopsies, cutaneous fat tissues biopsies, semen sample

Study summary

The main objective of the study is to evaluate the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in HIV-1 chronic patients in the main putative reservoirs, namely inguinal lymph nodes, rectal, fat tissues and sperm.

Eligibility

Sex

MALE

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Male HIV-1 infected subjects * Age \> or = 18 years old * Currently receiving as first line a stable ARV regimen containing bictegravir (at 50 mg once a day) and two nucleoside reverse transcriptase inhibitors, tenofovir alafenamide/emtricitabine (Biktarvy) * HIV RNA \<50 Cp/mL, undetectable 6 months after treatment initiation and confirmed and 12 months after treatment initiation. * Normal laboratory value of TP and TCA and platelets numbers at screening * Written and informed consent signed by the person and the investigator (no later than the day of pre-inclusion and prior to any examination realized in the frame of the research / study / trial) (article L1122-1-1 of the Public Health Code) * Person affiliated or beneficiary of a social security scheme (article L1121-11 of the Public Health Code) (State Medical Aid or AME is not a social security scheme) Exclusion Criteria: * Single HIV-2 infection * Biopsies contraindication, taking anticoagulant and antiplatelet drugs are not allowed * Haemophilia * Symptomatic sexually transmitted infection * Being under guardianship or trusteeship mandate for future protection * Participate to another research involving human person, categories 1 or 2, * Associated treatments : carbamazepine, oxcarbazepine, phenytoin, phenobarbital, rifampicin, St. John's Wort.

Primary outcome measure(s)

Characterization of the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in sperm — At Day 0, At time T0 (before taking treatments)
Dosage of the different antiretroviral drugs molecules in sperm
Characterization of the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in lymph nodes — At Day 0, between T1 (maximum 3 hours after tacking treatments) and T3 (8 hours after taking treatments)
Dosage of the different antiretroviral drugs molecules in lymph nodes
Characterization of the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in fat tissues — At Day 0, between T1 (maximum 3 hours after tacking treatments) and T3 (8 hours after taking treatments)
Dosage of the different antiretroviral drugs molecules in fat tissues
Characterization of the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in rectal tissues — At Day 0, T1 (maximum 3 hours after taking treatment)
Dosage of the different antiretroviral drugs molecules in rectal tissues

Trial sites (6)

Facility	City	Region
Antoine-Beclere Hospita	Clamart	France
Bicetre Hospital	Le Kremlin-Bicêtre	France
Hotel Dieu Hospital	Paris	France
Necker Hospital	Paris	France
Pitie Salpetriere Hospital	Paris	France
Saint Antoine Hospital	Paris	France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05222945 on ClinicalTrials.gov ↗ ← All trials in France