Exploration of HIV Reservoirs (MUCOVIR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Objectif Recherche Vaccins SIDA
ClinicalTrials.gov Identifier:
NCT01019044
First received: November 24, 2009
Last updated: February 12, 2013
Last verified: February 2013

November 24, 2009
February 12, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01019044 on ClinicalTrials.gov Archive Site
  • Quantification of the HIV proviral DNA in the rectal mucosa biopsies and in the PPBMCs [ Time Frame: Single patient visit ] [ Designated as safety issue: No ]
  • Quantitative, phenotypic and functional description of the long-term immune reconstitution in the rectal mucosa biopsies [ Time Frame: Single patient visit ] [ Designated as safety issue: No ]
  • Quantification of HIV proviral DNA in the total CD4 lymphocytes [ Time Frame: Single patient visit ] [ Designated as safety issue: No ]
  • Pharmacokinetics of the antiretroviral molecules in the rectal mucosa biopsies and in the blood [ Time Frame: Single patient visit ] [ Designated as safety issue: No ]
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:

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, Lecardonel 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 patients. J Acquir Immune Defic Syndr. 2012 Dec 28. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01019044
ORVACS 009
No
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP