Exploration of HIV Reservoirs

NCT ID: NCT01019044

Last Updated: 2013-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-11-30

Brief Summary

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

Detailed Description

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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).

Conditions

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HIV-1 Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Rectal mucosa biopsy

Rectal mucosa samples collection

Rectal mucosa biopsy

Intervention Type PROCEDURE

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

Interventions

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Rectal mucosa biopsy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Objectif Recherche Vaccins SIDA

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine KATLAMA, MD

Role: PRINCIPAL_INVESTIGATOR

Groupe Hospitalier Pitié-Salpêtrière

François LECARDONNEL, MSc

Role: STUDY_DIRECTOR

ORVACS

Locations

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Groupe Hospitalier Pitié-Salpêtrière

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 23274932 (View on PubMed)

Other Identifiers

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ORVACS 009

Identifier Type: -

Identifier Source: org_study_id

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