Status:
COMPLETED
Cartography of Virologic Reservoir Related to Antiretroviral Concentrations in HIV-1 Chronic Patients Treated by a First Line Treatment Containing Dolutegravir and Associated Nucleoside / Nucleotide Reverse Transcriptase Inhibitors Backbone
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
ViiV Healthcare
Conditions:
HIV-1 Infection
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
The main objective of the study is to characterize the diffusion of dolutegravir and associated backbone (abacavir/lamivudine or tenofovir/emtricitabine) in HIV-1 chronic patients in the main putative...
Detailed Description
The major obstacle to a functional cure of HIV infection is the persistence of the latent HIV reservoir. Several arguments suggest the persistence of a residual viral replication in different compart...
Eligibility Criteria
Inclusion
- Male HIV-1 infected subjects
- Age \> or = 18 years old
- Currently receiving as first line therapy 7 days a week for at least 18 months with dolutegravir (at 50 mg once a day) and two nucleoside/nucleotide reverse transcriptase inhibitors (abacavir/lamivudine or ,tenofovir/emtricitabine) or
- Receiving first-line therapy 7 days a week for at least 18 months with dolutegravir (50 mg once daily) + abacavir/lamivudine followed by dual therapy with dolutegravir + lamivudine for at least 6 months; or
- Receiving first-line therapy 7 days a week for at least 18 months with dolutegravir + tenofovir / emtricitabine followed by dual therapy with dolutegravir + lamivudine for at least 6 months.
- HIV RNA currently \<50 Cp/mL, , and \<50 Cp/mL 6 months after treatment initiation and \<50 Cp/mL confirmed at 12 months after treatment initiation
- Normal PT, APTT and platelet count values at screening
- Written and informed consent signed by the person and the investigator (no later than the day of pre-enrollment and prior to any examination carried out as part of the study (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
- Dolutegravir antiretroviral monotherapy
- Contraindication to biopsy, taking anticoagulant and antiplatelet drugs
- Hemophilia
- Symptomatic sexually transmitted infection
- Being under guardianship or trusteeship mandate for future protection
- Participation in another research involving the human person, of category 1 or 2,
- Associated treatments (Carbamazepine, Oxcarbazepine, Phenytoin, Phenobarbital, Rifampicin, St. John's Wort)
Key Trial Info
Start Date :
February 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 9 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04133012
Start Date
February 10 2020
End Date
June 9 2023
Last Update
September 3 2024
Active Locations (8)
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1
Antoine-Beclere Hospital
Clamart, France
2
Bicetre Hospital
Le Kremlin-Bicêtre, France
3
Saint Antoine Hospital
Paris, France, 75012
4
Bichat Hospital
Paris, France