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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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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.
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, Necker, Hôtel-Dieu and Saint-Antoine Hospitals will be recruited.
Different samples will be performed during one single day:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm composed by 34 HIV-1 infected male subjects | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsies and bloood samplings | Other | blood samples, rectal biopsies, nodes biopsies, cutaneous fat tissues biopsies, semen sample |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Characterization of the level of the replication (RNA-HIV) in the reservoirs | Analyze and comparison of the level of viral transcription by measuring the cell-associated HIV- RNA in the different tissues and fluids: lymphoid, rectal, genital secretion, blood and fat biopsies as well as cerebrospinal fluid. | At Day 0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fatoumata Coulibaly | Contact | +331 44 23 61 10 | fatoumata.coulibay@inserm.fr | |
| Sophie LETROU | Contact | +331 40 25 65 81 | sophie.letrou@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Antoine CHERET, Pr | Centre de Diagnostic et de Thérapeutique pluridisciplinaire CHU Pointe-à-Pitre/Abymes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antoine-Beclere Hospita | Clamart | France |
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| Characterization of the level of infection (DNA-HIV) in the reservoirs |
Analyze and comparison of the reservoir level by measuring the cell-associated total HIV- DNA in the different tissues and fluids |
| At Day 0 |
| Study of the spatial dynamics of viral quasi-species In the different reservoirs | Analyze of the spatial dynamics of HIV-DNA and HIV-RNA from Lymphoid, rectal, genital secretion, blood, fat cells by phylogenetic analyses after sequencing Env HIV-DNA and HIV-RNA | At Day 0 |
| Study of the mutations of resistance in the integrase gene | Description of resistance mutations in Integrase gene which could be linked to suboptimal concentrations of bictegravir | At Day 0 |
| Description for each compartment of the relationship between exposure to therapeutic combinations and the level of infection / viral replication | Characterization of the relationship between the concentration of bictegravir and backbone drugs with the level of wild type viral replication in the different compartments. Analyze of the impact of backbone drugs associated to bictegravir on viral level production. Correlation between the level of resistant virus replication and the exposure to bictegravir and the backbone drugs. Evaluation by simulation the effect of different dosing regimen of bictegravir (including higher doses) on the level of viral replication and on resistance | At Day 0 |
| 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 |
|
| ID | Term |
|---|---|
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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