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Trial record 20 of 31 for:    " November 11, 2009":" December 11, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Exploration of HIV Reservoirs (MUCOVIR)

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

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy HIV/AIDS

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




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


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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01019044


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