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Exploration of HIV Reservoirs (MUCOVIR)

This study has been completed.
Information provided by (Responsible Party):
Objectif Recherche Vaccins SIDA Identifier:
First received: November 24, 2009
Last updated: February 12, 2013
Last verified: February 2013
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 Intervention
HIV-1 Infection
Procedure: Rectal mucosa biopsy

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Objectif Recherche Vaccins SIDA:

Primary Outcome Measures:
  • 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:
  • 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 ]

Biospecimen Retention:   None Retained
Plasma and total blood samples A maximum of 15 rectal mucosa biopsy samples

Enrollment: 11
Study Start Date: May 2009
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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).

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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
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Please refer to this study by its identifier: NCT01019044

Groupe Hospitalier Pitié-Salpêtrière
Paris, France, 75013
Sponsors and Collaborators
Objectif Recherche Vaccins SIDA
Principal Investigator: Christine KATLAMA, MD Groupe Hospitalier Pitié-Salpêtrière
Study Director: François LECARDONNEL, MSc ORVACS
  More Information

Responsible Party: Objectif Recherche Vaccins SIDA Identifier: NCT01019044     History of Changes
Other Study ID Numbers: ORVACS 009
Study First Received: November 24, 2009
Last Updated: February 12, 2013

Keywords provided by Objectif Recherche Vaccins SIDA:
Viral reservoirs
Viral load processed this record on May 22, 2017