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, Emerging Infectious Diseases

Status

Not yet enrolling

Conditions

HIV-1-infection

Treatments

Other: Biopsies and bloood samplings

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05222945

ANRS EP69 BICTEVOIR

Details and patient eligibility

About

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.

Full 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)

Enrollment

34 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No 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.