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 | Not Yet Recruiting

• 1 other identifier: ANRS EP69 BICTEVOIR
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 6

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.

Conditions

HIV-1-infection

Keywords

Viral cartography; Viral reservoir; Antiretroviral treatments diffusion

Outcome Measures

Primary Outcomes (4)

• Characterization of the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in sperm

  Dosage of the different antiretroviral drugs molecules in sperm

  At Day 0, At time T0 (before taking treatments)

• Characterization of the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in lymph nodes

  Dosage of the different antiretroviral drugs molecules in lymph nodes

  At Day 0, between T1 (maximum 3 hours after tacking treatments) and T3 (8 hours after taking treatments)

• Characterization of the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in fat tissues

  Dosage of the different antiretroviral drugs molecules in fat tissues

  At Day 0, between T1 (maximum 3 hours after tacking treatments) and T3 (8 hours after taking treatments)

• Characterization of the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in rectal tissues

  Dosage of the different antiretroviral drugs molecules in rectal tissues

  At Day 0, T1 (maximum 3 hours after taking treatment)

Secondary Outcomes (5)

• Characterization of the level of the replication (RNA-HIV) in the reservoirs

  At Day 0

• Characterization of the level of infection (DNA-HIV) in the reservoirs

  At Day 0

• Study of the spatial dynamics of viral quasi-species In the different reservoirs

  At Day 0

• Study of the mutations of resistance in the integrase gene

  At Day 0

• Description for each compartment of the relationship between exposure to therapeutic combinations and the level of infection / viral replication

  At Day 0

Study Arms (1)

Single arm composed by 34 HIV-1 infected male subjects

OTHER

Other: Biopsies and bloood samplings

Interventions

Biopsies and bloood samplings OTHER

blood samples, rectal biopsies, nodes biopsies, cutaneous fat tissues biopsies, semen sample

Single arm composed by 34 HIV-1 infected male subjects

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Gilead Sciences: collaborator

Study Sites (6)

Antoine-Beclere Hospita

Clamart, France

Location

Bicetre Hospital

Le Kremlin-Bicêtre, France

Location

Hotel Dieu Hospital

Paris, France

Location

Necker Hospital

Paris, France

Location

Pitie Salpetriere Hospital

Paris, France

Location

Saint Antoine Hospital

Paris, France

Location

MeSH Terms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Antoine CHERET, Pr

  Centre de Diagnostic et de Thérapeutique pluridisciplinaire CHU Pointe-à-Pitre/Abymes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatoumata Coulibaly

CONTACT

+331 44 23 61 10; fatoumata.coulibay@inserm.fr

Sophie LETROU

CONTACT

+331 40 25 65 81; sophie.letrou@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: February 3, 2022
• Study Start: April 1, 2025
• Primary Completion: October 30, 2025
• Study Completion: October 31, 2025
• Last Updated: February 5, 2025

Record last verified: 2025-02

Locations

FR (6)