HIV-1 Infection
Conditions
Keywords
HIV, Viral reservoirs, Viral load
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.
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).
Interventions
PROCEDURERectal mucosa biopsy
Collection of a maximum of 15 rectal mucosa samples in the high portion of the rectum near the rectosigmoidal junction
Sponsors
Objectif Recherche Vaccins SIDA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantification of the HIV-RNA plasma viral load using ultrasensible assay (limit of detection: 1 copy/ml) | Single patient visit |
Secondary
| Measure | 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 |
Countries
France
Outcome results
None listed