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

Tracking Information

• First Submitted Date: November 24, 2009
• First Posted Date: November 25, 2009
• Last Update Posted Date: February 13, 2013
• Study Start Date: May 2009
• Actual Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 24, 2009): Quantification of the HIV-RNA plasma viral load using ultrasensible assay (limit of detection: 1 copy/ml) [ Time Frame: Single patient visit ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 24, 2009)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Exploration of HIV Reservoirs
• Official Title: Virologic and Immunologic Evaluation of the Deep Viral Reservoirs in HIV-1 Infected Patients With Long Term Viral Suppression
• 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   None Retained

Description:

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

• Sampling Method: Non-Probability Sample
• Study Population: HIV-1 infected patients followed in specialized infectious disease/HIV hospital department
• Condition: HIV-1 Infection

Intervention

Procedure: Rectal mucosa biopsy

Collection of a maximum of 15 rectal mucosa samples in the high portion of the rectum near the rectosigmoidal junction

Study Groups/Cohorts

Rectal mucosa biopsy

Rectal mucosa samples collection

Intervention: Procedure: Rectal mucosa biopsy

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 24, 2009): 11
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: November 2009
• Actual Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01019044
• Other Study ID Numbers: ORVACS 009
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Objectif Recherche Vaccins SIDA
• Study Sponsor: Objectif Recherche Vaccins SIDA
• Collaborators: Not Provided

Investigators

• Principal Investigator: Christine KATLAMA, MD; Groupe Hospitalier Pitié-Salpêtrière
• Study Director: François LECARDONNEL, MSc; ORVACS

• PRS Account: Objectif Recherche Vaccins SIDA
• Verification Date: February 2013