Exploration of HIV Reservoirs (MUCOVIR)

• ClinicalTrials.gov Identifier: NCT01019044
• Recruitment Status: Completed
• First Posted: November 25, 2009
• Last Update Posted: February 13, 2013
• Sponsor: Objectif Recherche Vaccins SIDA
• Information provided by (Responsible Party): Objectif Recherche Vaccins SIDA

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
HIV-1 Infection	Procedure: Rectal mucosa biopsy

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

• Study Type: Observational
• Actual Enrollment: 11 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Virologic and Immunologic Evaluation of the Deep Viral Reservoirs in HIV-1 Infected Patients With Long Term Viral Suppression
• Study Start Date: May 2009
• Actual Primary Completion Date: October 2009
• Actual Study Completion Date: November 2009

Groups and Cohorts

Group/Cohort	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 :

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

Secondary Outcome Measures :

1. Quantification of the HIV proviral DNA in the rectal mucosa biopsies and in the PPBMCs [ Time Frame: Single patient visit ]
2. Quantitative, phenotypic and functional description of the long-term immune reconstitution in the rectal mucosa biopsies [ Time Frame: Single patient visit ]
3. Quantification of HIV proviral DNA in the total CD4 lymphocytes [ Time Frame: Single patient visit ]
4. Pharmacokinetics of the antiretroviral molecules in the rectal mucosa biopsies and in the blood [ Time Frame: Single patient visit ]

Biospecimen Retention:   None Retained

Plasma and total blood samples A maximum of 15 rectal mucosa biopsy samples

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

HIV-1 infected patients followed in specialized infectious disease/HIV hospital department

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:

• 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

France

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

More Information

Publications of Results:

Descours B, Lambert-Niclot S, Mory B, Samri A, Charlotte F, Peytavin G, Tubiana R, Papagno L, Bacchus C, Lecardonnel F, Katlama C, Autran B, Marcelin AG, Valantin MA, Carcelain G; DECAMUNE and ORVACS Study Groups. Direct quantification of cell-associated HIV DNA in isolated rectal and blood memory CD4 T cells revealed their similar and low infection levels in long-term treated HIV-infected patients. J Acquir Immune Defic Syndr. 2013 Mar 1;62(3):255-9. doi: 10.1097/QAI.0b013e318282537f.

• Responsible Party: Objectif Recherche Vaccins SIDA
• ClinicalTrials.gov Identifier: NCT01019044
• Other Study ID Numbers: ORVACS 009
• First Posted: November 25, 2009
• Last Update Posted: February 13, 2013
• Last Verified: February 2013

Keywords provided by Objectif Recherche Vaccins SIDA:

HIV; Viral reservoirs; Viral load