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
NCT ID: NCT05222945
Last Updated: 2025-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
34 participants
INTERVENTIONAL
2025-04-01
2025-10-31
Brief Summary
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Detailed Description
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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)
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Single arm composed by 34 HIV-1 infected male subjects
Biopsies and bloood samplings
blood samples, rectal biopsies, nodes biopsies, cutaneous fat tissues biopsies, semen sample
Interventions
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Biopsies and bloood samplings
blood samples, rectal biopsies, nodes biopsies, cutaneous fat tissues biopsies, semen sample
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
MALE
No
Sponsors
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Gilead Sciences
INDUSTRY
ANRS, Emerging Infectious Diseases
OTHER_GOV
Responsible Party
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Principal Investigators
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Antoine CHERET, Pr
Role: PRINCIPAL_INVESTIGATOR
Centre de Diagnostic et de Thérapeutique pluridisciplinaire CHU Pointe-à-Pitre/Abymes
Locations
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Antoine-Beclere Hospita
Clamart, , France
Bicetre Hospital
Le Kremlin-Bicêtre, , France
Hotel Dieu Hospital
Paris, , France
Necker Hospital
Paris, , France
Pitie Salpetriere Hospital
Paris, , France
Saint Antoine Hospital
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Sophie ABGRALL
Role: primary
Elina TEICHER
Role: primary
Dominique SALMON-CERON
Role: primary
Claudine Duvivier
Role: primary
Valérie MARTINEZ
Role: primary
Karine LACOMBE
Role: primary
Other Identifiers
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ANRS EP69 BICTEVOIR
Identifier Type: -
Identifier Source: org_study_id
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