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

Study Description

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 Design


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

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

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 ]

Secondary Outcome Measures :

Quantification of the HIV proviral DNA in the rectal mucosa biopsies and in the PPBMCs [ Time Frame: Single patient visit ]
Quantitative, phenotypic and functional description of the long-term immune reconstitution in the rectal mucosa biopsies [ Time Frame: Single patient visit ]
Quantification of HIV proviral DNA in the total CD4 lymphocytes [ Time Frame: Single patient visit ]
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

Eligibility Criteria

Information from the National Library of Medicine

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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)

Contacts and Locations

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

More Information

Publications of Results:

Descours B, Lambert-Niclot S, Mory B, Samri A, Charlotte F, Peytavin G, Tubiana R, Papagno L, Bacchus C, Lecardonnel 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 HIV-infected patients. J Acquir Immune Defic Syndr. 2013 Mar 1;62(3):255-9. doi: 10.1097/QAI.0b013e318282537f.


Responsible Party:	Objectif Recherche Vaccins SIDA
ClinicalTrials.gov Identifier:	NCT01019044 History of Changes
Other Study ID Numbers:	ORVACS 009
First Posted:	November 25, 2009 Key Record Dates
Last Update Posted:	February 13, 2013
Last Verified:	February 2013

Keywords provided by Objectif Recherche Vaccins SIDA:


HIV Viral reservoirs Viral load

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