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OpenTrials
Completed

NCT Number: NCT01019044

Exploration of HIV Reservoirs

Prospective study in HIV-1 infected patients with a plasma viral load below the limit of detection and stable for at least 5 years.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Pitié-Salpêtrière

Paris, 75013, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Rectal mucosa biopsy

Procedure

Collection of a maximum of 15 rectal mucosa samples in the high portion of the rectum near the rectosigmoidal junction

Primary outcomes

  1. Quantification of the HIV-RNA plasma viral load using ultrasensible assay (limit of detection: 1 copy/ml)

    Time frame: Single patient visit

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Objectif Recherche Vaccins SIDA

Other

Registry information

Official study title

Virologic and Immunologic Evaluation of the Deep Viral Reservoirs in HIV-1 Infected Patients With Long Term Viral Suppression

Acronym: MUCOVIR

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Nov 25, 2009
Registry last updated
Feb 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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