Exploration of HIV Reservoirs

Completed

• Conditions: HIV-1 Infection
• Interventions: Procedure: Rectal mucosa biopsy

• Registration Number: NCT01019044
• Lead Sponsor: Objectif Recherche Vaccins SIDA

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).

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2009-10
• Study Completion: 2009-11
• Study First Submitted: 2009-11-24
• Study First Submitted QC: 2009-11-24
• Study First Posted: 2009-11-25
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-12
• Last Update Posted: 2013-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rectal mucosa biopsy	Rectal mucosa biopsy	Rectal mucosa samples collection

Primary Outcome Measures

Name	Time	Method
Quantification of the HIV-RNA plasma viral load using ultrasensible assay (limit of detection: 1 copy/ml)	Single patient visit

Secondary Outcome Measures

Name	Time	Method
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
Quantification of the HIV proviral DNA in the rectal mucosa biopsies and in the PPBMCs	Single patient visit

Trial Locations

Locations (1)

Groupe Hospitalier Pitié-Salpêtrière; 🇫🇷 Paris, France