MUCOVIR: Exploration of HIV Reservoirs
Study Details
Study Description
Brief Summary
Prospective study in HIV-1 infected patients with a plasma viral load below the limit of detection and stable for at least 5 years.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Rectal mucosa biopsy Rectal mucosa samples collection |
Procedure: Rectal mucosa biopsy
Collection of a maximum of 15 rectal mucosa samples in the high portion of the rectum near the rectosigmoidal junction
|
Outcome Measures
Primary Outcome Measures
- Quantification of the HIV-RNA plasma viral load using ultrasensible assay (limit of detection: 1 copy/ml) [Single patient visit]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
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:
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Groupe Hospitalier Pitié-Salpêtrière | Paris | France | 75013 |
Sponsors and Collaborators
- Objectif Recherche Vaccins SIDA
Investigators
- Principal Investigator: Christine KATLAMA, MD, Groupe Hospitalier Pitié-Salpêtrière
- Study Director: François LECARDONNEL, MSc, ORVACS
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ORVACS 009