Exploration of HIV Reservoirs (MUCOVIR)

February 12, 2013 updated by: Objectif Recherche Vaccins SIDA

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Groupe Hospitalier Pitie-Salpetriere

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

HIV-1 infected patients followed in specialized infectious disease/HIV hospital department

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quantification of the HIV-RNA plasma viral load using ultrasensible assay (limit of detection: 1 copy/ml)
Time Frame: Single patient visit
Single patient visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Quantification of the HIV proviral DNA in the rectal mucosa biopsies and in the PPBMCs
Time Frame: Single patient visit
Single patient visit
Quantitative, phenotypic and functional description of the long-term immune reconstitution in the rectal mucosa biopsies
Time Frame: Single patient visit
Single patient visit
Quantification of HIV proviral DNA in the total CD4 lymphocytes
Time Frame: Single patient visit
Single patient visit
Pharmacokinetics of the antiretroviral molecules in the rectal mucosa biopsies and in the blood
Time Frame: Single patient visit
Single patient visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Objectif Recherche Vaccins SIDA

Investigators

  • Principal Investigator: Christine Katlama, MD, Groupe Hospitalier Pitie-Salpetriere
  • Study Director: François LECARDONNEL, MSc, ORVACS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

November 24, 2009

First Submitted That Met QC Criteria

November 24, 2009

First Posted (Estimate)

November 25, 2009

Study Record Updates

Last Update Posted (Estimate)

February 13, 2013

Last Update Submitted That Met QC Criteria

February 12, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ORVACS 009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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