Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
Gilead Sciences
Conditions:
HIV-1-infection
Eligibility:
MALE
18+ years
Phase:
NA
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,...
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,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2025
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT05222945
Start Date
April 1 2025
End Date
October 31 2025
Last Update
February 5 2025
Active Locations (6)
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1
Antoine-Beclere Hospita
Clamart, France
2
Bicetre Hospital
Le Kremlin-Bicêtre, France
3
Hotel Dieu Hospital
Paris, France
4
Necker Hospital
Paris, France