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
  Purpose

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Objectif Recherche Vaccins SIDA
ClinicalTrials.gov Identifier: NCT01019044     History of Changes
Other Study ID Numbers: ORVACS 009
Study First Received: November 24, 2009
Last Updated: February 12, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Objectif Recherche Vaccins SIDA:
HIV
Viral reservoirs
Viral load

ClinicalTrials.gov processed this record on October 22, 2014