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
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Condition or disease | Intervention/treatment |
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HIV-1 Infection | Procedure: Rectal mucosa biopsy |
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 |

Group/Cohort | Intervention/treatment |
---|---|
Rectal mucosa biopsy
Rectal mucosa samples collection
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Procedure: Rectal mucosa biopsy
Collection of a maximum of 15 rectal mucosa samples in the high portion of the rectum near the rectosigmoidal junction |
- Quantification of the HIV-RNA plasma viral load using ultrasensible assay (limit of detection: 1 copy/ml) [ Time Frame: Single patient visit ]
- 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

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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 |
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)

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
France | |
Groupe Hospitalier Pitié-Salpêtrière | |
Paris, France, 75013 |
Principal Investigator: | Christine KATLAMA, MD | Groupe Hospitalier Pitié-Salpêtrière | |
Study Director: | François LECARDONNEL, MSc | ORVACS |
Responsible Party: | Objectif Recherche Vaccins SIDA |
ClinicalTrials.gov Identifier: | NCT01019044 |
Other Study ID Numbers: |
ORVACS 009 |
First Posted: | November 25, 2009 Key Record Dates |
Last Update Posted: | February 13, 2013 |
Last Verified: | February 2013 |
HIV Viral reservoirs Viral load |