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
- Conditions
- HIV-1-infection
- Registration Number
- NCT05222945
- Lead Sponsor
- ANRS, Emerging Infectious Diseases
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Male HIV-1 infected subjects<br><br> - Age > or = 18 years old<br><br> - Currently receiving as first line a stable ARV regimen containing bictegravir (at 50<br> mg once a day) and two nucleoside reverse transcriptase inhibitors, tenofovir<br> alafenamide/emtricitabine (Biktarvy)<br><br> - HIV RNA <50 Cp/mL, undetectable 6 months after treatment initiation and confirmed<br> and 12 months after treatment initiation.<br><br> - Normal laboratory value of TP and TCA and platelets numbers at screening<br><br> - Written and informed consent signed by the person and the investigator (no later<br> than the day of pre-inclusion and prior to any examination realized in the frame of<br> the research / study / trial) (article L1122-1-1 of the Public Health Code)<br><br> - Person affiliated or beneficiary of a social security scheme (article L1121-11 of<br> the Public Health Code) (State Medical Aid or AME is not a social security scheme)<br><br>Exclusion Criteria:<br><br> - Single HIV-2 infection<br><br> - Biopsies contraindication, taking anticoagulant and antiplatelet drugs are not<br> allowed<br><br> - Haemophilia<br><br> - Symptomatic sexually transmitted infection<br><br> - Being under guardianship or trusteeship mandate for future protection<br><br> - Participate to another research involving human person, categories 1 or 2,<br><br> - Associated treatments : carbamazepine, oxcarbazepine, phenytoin, phenobarbital,<br> rifampicin, St. John's Wort.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Characterization of the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in sperm;Characterization of the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in lymph nodes;Characterization of the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in fat tissues;Characterization of the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in rectal tissues
- Secondary Outcome Measures
Name Time Method Characterization of the level of the replication (RNA-HIV) in the reservoirs;Characterization of the level of infection (DNA-HIV) in the reservoirs;Study of the spatial dynamics of viral quasi-species In the different reservoirs;Study of the mutations of resistance in the integrase gene;Description for each compartment of the relationship between exposure to therapeutic combinations and the level of infection / viral replication