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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

Tracking Information
First Submitted Date November 24, 2009
First Posted Date November 25, 2009
Last Update Posted Date February 13, 2013
Study Start Date May 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 24, 2009)
Quantification of the HIV-RNA plasma viral load using ultrasensible assay (limit of detection: 1 copy/ml) [ Time Frame: Single patient visit ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 24, 2009)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Exploration of HIV Reservoirs
Official Title Virologic and Immunologic Evaluation of the Deep Viral Reservoirs in HIV-1 Infected Patients With Long Term Viral Suppression
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
Plasma and total blood samples A maximum of 15 rectal mucosa biopsy samples
Sampling Method Non-Probability Sample
Study Population HIV-1 infected patients followed in specialized infectious disease/HIV hospital department
Condition 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
Study Groups/Cohorts Rectal mucosa biopsy
Rectal mucosa samples collection
Intervention: Procedure: Rectal mucosa biopsy
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 24, 2009)
11
Original Actual Enrollment Same as current
Actual Study Completion Date November 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01019044
Other Study ID Numbers ORVACS 009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Objectif Recherche Vaccins SIDA
Study Sponsor Objectif Recherche Vaccins SIDA
Collaborators Not Provided
Investigators
Principal Investigator: Christine KATLAMA, MD Groupe Hospitalier Pitié-Salpêtrière
Study Director: François LECARDONNEL, MSc ORVACS
PRS Account Objectif Recherche Vaccins SIDA
Verification Date February 2013