NCT05222945

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

ANRS EP69 BICTEVOIR : A Prospective 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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

ANRS EP69 BICTEVOIR is an interventional pilot study, multicenter, involving the use of human biological samples. 34 HIV-1 infected male subjects, from Bicetre, La Pitié Salpêtriere, Antoine-Béclère, Necker, Hôtel-Dieu and Saint-Antoine Hospitals will be recruited. Different samples will be performed during one single day: * blood samples * rectal biopsies * nodes biopsies * cutaneous fat tissues biopsies * semen sample (at home)

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
OTHER	Biopsies and bloood samplings	blood samples, rectal biopsies, nodes biopsies, cutaneous fat tissues biopsies, semen sample

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-10-30
• Completion: 2025-10-31
• First posted: 2022-02-03
• Last updated: 2025-02-05

Locations

6 sites across 1 country: France