Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV-1-infection
Keywords: Viral cartography
Viral reservoir
Antiretroviral treatments diffusion
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Gilead Sciences
First posted: 2022-02-03
Enrollment: 34
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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)

Eligibility criteria: 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 outcomes:
measure: Characterization of the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in sperm
timeFrame: At Day 0, At time T0 (before taking treatments)
measure: Characterization of the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in lymph nodes
timeFrame: At Day 0, between T1 (maximum 3 hours after tacking treatments) and T3 (8 hours after taking treatments)
measure: Characterization of the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in fat tissues
timeFrame: At Day 0, between T1 (maximum 3 hours after tacking treatments) and T3 (8 hours after taking treatments)
measure: Characterization of the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in rectal tissues
timeFrame: At Day 0, T1 (maximum 3 hours after taking treatment)
Secondary outcomes:
measure: Characterization of the level of the replication (RNA-HIV) in the reservoirs
timeFrame: At Day 0
measure: Characterization of the level of infection (DNA-HIV) in the reservoirs
timeFrame: At Day 0
measure: Study of the spatial dynamics of viral quasi-species In the different reservoirs
timeFrame: At Day 0
measure: Study of the mutations of resistance in the integrase gene
timeFrame: At Day 0
measure: Description for each compartment of the relationship between exposure to therapeutic combinations and the level of infection / viral replication
timeFrame: At Day 0
Other outcomes:
Locations:
city: Clamart
country: France
facility: Antoine-Beclere Hospita
city: Le Kremlin-Bicêtre
country: France
facility: Bicetre Hospital
city: Paris
country: France
facility: Hotel Dieu Hospital
city: Paris
country: France
facility: Necker Hospital
city: Paris
country: France
facility: Pitie Salpetriere Hospital
city: Paris
country: France
facility: Saint Antoine Hospital
Study officials:
affiliation: Centre de Diagnostic et de Thérapeutique pluridisciplinaire CHU Pointe-à-Pitre/Abymes
name: Antoine CHERET, Pr
role: PRINCIPAL_INVESTIGATOR
References: