Exploration of HIV Reservoirs (MUCOVIR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01019044
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : February 13, 2013
Information provided by (Responsible Party):
Objectif Recherche Vaccins SIDA

November 24, 2009
November 25, 2009
February 13, 2013
May 2009
October 2009   (Final data collection date for primary outcome measure)
Quantification of the HIV-RNA plasma viral load using ultrasensible assay (limit of detection: 1 copy/ml) [ Time Frame: Single patient visit ]
Same as current
Complete list of historical versions of study NCT01019044 on Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
Exploration of HIV Reservoirs
Virologic and Immunologic Evaluation of the Deep Viral Reservoirs in HIV-1 Infected Patients With Long Term Viral Suppression
Prospective study in HIV-1 infected patients with a plasma viral load below the limit of detection and stable for at least 5 years.
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).
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Plasma and total blood samples A maximum of 15 rectal mucosa biopsy samples
Non-Probability Sample
HIV-1 infected patients followed in specialized infectious disease/HIV hospital department
HIV-1 Infection
Procedure: Rectal mucosa biopsy
Collection of a maximum of 15 rectal mucosa samples in the high portion of the rectum near the rectosigmoidal junction
Rectal mucosa biopsy
Rectal mucosa samples collection
Intervention: Procedure: Rectal mucosa biopsy
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
November 2009
October 2009   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Objectif Recherche Vaccins SIDA
Objectif Recherche Vaccins SIDA
Not Provided
Principal Investigator: Christine KATLAMA, MD Groupe Hospitalier Pitié-Salpêtrière
Study Director: François LECARDONNEL, MSc ORVACS
Objectif Recherche Vaccins SIDA
February 2013