Exploration of HIV Reservoirs

Study Overview
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Brief Summary
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Prospective study in HIV-1 infected patients with a plasma viral load below the limit of detection and stable for at least 5 years.

Detailed Description
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Evaluation of the mucosal HIV reservoirs (HIV-DNA quantification and distribution of the infected T lymphocytes in the gut mucosa associated lymphoid tissue compared to the blood in HIV-1 infected patients under antiretroviral treatment with an undetectable plasma viral load below the 50 copies/ml limit of detection for at least 5 years).

Official Title
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Virologic and Immunologic Evaluation of the Deep Viral Reservoirs in HIV-1 Infected Patients With Long Term Viral Suppression

Conditions
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HIV-1 Infection

Intervention / Treatment
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* Procedure: Rectal mucosa biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-1 documented infection HIV-1 plasma viral load measurable before antiretroviral treatment initiation Patients treated with an antiretroviral combination containing a protease inhibitor and/or a non-nucleosidic reverse transcriptase inhibitor without any interruption since treatment initiation Patients with a stable plasma viral load below the limit of detection (HIV-RNA < 50 copies/ml since January 2006 and/or HIV-RNA < 200 copies/ml during the anterior period) under antiretroviral treatment for at least 5 years and for at least 90 % of the measures Exclusion Criteria: Contraindication to the biopsy No ability or willingness to provide informed consent Concomitant treatment with antithrombotics or platelets antiaggregatory Patients co-infected with HCV and or HBV Patients who received an immunosuppressive treatment during 3 months prior enrollment (chemotherapy, radiotherapy, corticotherapy, splenectomy) or an immunotherapy during 5 years prior enrolment (IL-2, anti-HIV vaccine, IFN-alpha)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rectal mucosa biopsy<br>Rectal mucosa samples collection | Procedure: Rectal mucosa biopsy<br>* Collection of a maximum of 15 rectal mucosa samples in the high portion of the rectum near the rectosigmoidal junction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of the HIV-RNA plasma viral load using ultrasensible assay (limit of detection: 1 copy/ml) |  | Single patient visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of the HIV proviral DNA in the rectal mucosa biopsies and in the PPBMCs |  | Single patient visit | 
| Quantitative, phenotypic and functional description of the long-term immune reconstitution in the rectal mucosa biopsies |  | Single patient visit | 
| Quantification of HIV proviral DNA in the total CD4 lymphocytes |  | Single patient visit | 
| Pharmacokinetics of the antiretroviral molecules in the rectal mucosa biopsies and in the blood |  | Single patient visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Viral reservoirs, Viral load