Exploration of HIV Reservoirs

NCT01019044 | Completed

• 1 other identifier: ORVACS 009
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-1 Infection

Keywords

HIV; Viral reservoirs; Viral load

Outcome Measures

Primary Outcomes (1)

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

  Single patient visit

Secondary Outcomes (4)

• Quantification of the HIV proviral DNA in the rectal mucosa biopsies and in the PPBMCs

  Single patient visit

• Quantitative, phenotypic and functional description of the long-term immune reconstitution in the rectal mucosa biopsies

  Single patient visit

• Quantification of HIV proviral DNA in the total CD4 lymphocytes

  Single patient visit

• Pharmacokinetics of the antiretroviral molecules in the rectal mucosa biopsies and in the blood

  Single patient visit

Study Arms (1)

Rectal mucosa biopsy

Rectal mucosa samples collection

Procedure: Rectal mucosa biopsy

Interventions

Rectal mucosa biopsy PROCEDURE

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

Rectal mucosa biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Objectif Recherche Vaccins SIDA: lead

Study Sites (1)

Groupe Hospitalier Pitié-Salpêtrière

Paris, 75013, France

Location

Related 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 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.

  PMID: 23274932 RESULT

Biospecimen

Retention: NONE RETAINED

Plasma and total blood samples A maximum of 15 rectal mucosa biopsy samples

Study Officials

• Christine KATLAMA, MD

  Groupe Hospitalier Pitié-Salpêtrière

  PRINCIPAL INVESTIGATOR

• François LECARDONNEL, MSc

  ORVACS

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2009
• First Posted: November 25, 2009
• Study Start: May 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2009
• Last Updated: February 13, 2013

Record last verified: 2013-02

Locations

FR (1)