Exploration of HIV Reservoirs

HIV-1 Infection Clinical Trial

— MUCOVIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01019044
• Other study ID #: ORVACS 009
• Status: Completed
• Phase: N/A
• First received: November 24, 2009
• Last updated: February 12, 2013
• Start date: May 2009
• Est. completion date: November 2009

Study information

• Verified date: February 2013
• Source: Objectif Recherche Vaccins SIDA
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: November 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV-1 Infection

Intervention

Procedure:
• Rectal mucosa biopsy
Collection of a maximum of 15 rectal mucosa samples in the high portion of the rectum near the rectosigmoidal junction

Locations

Country	Name	City	State
France	Groupe Hospitalier Pitié-Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Objectif Recherche Vaccins SIDA

Country where clinical trial is conducted

France, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantification of the HIV-RNA plasma viral load using ultrasensible assay (limit of detection: 1 copy/ml)		Single patient visit	No
Secondary	Quantification of the HIV proviral DNA in the rectal mucosa biopsies and in the PPBMCs		Single patient visit	No
Secondary	Quantitative, phenotypic and functional description of the long-term immune reconstitution in the rectal mucosa biopsies		Single patient visit	No
Secondary	Quantification of HIV proviral DNA in the total CD4 lymphocytes		Single patient visit	No
Secondary	Pharmacokinetics of the antiretroviral molecules in the rectal mucosa biopsies and in the blood		Single patient visit	No