- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03298360
A Chronological Study of the Formation of HIV Cellular Reservoirs Through the Expression of Surface Markers on CD4 + T Lymphocytes, Including CD32a (ANRS EP63)
Study Overview
Detailed Description
Objectives
Principal objective
To analyze the HIV viral sequences present in the CD32 + CD4a + T lymphocytes of the patients who have participated in the ANRS 139 TRIO trial, always followed and in virological success, and carrying multi-resistant viruses archived in the HIV cell reservoir, in order to reconstruct the chronology of the installation of this reservoir.
Secondary objectives
To analyze the HIV viral sequences present in the CD4 + lymphocytes with other membrane HIV reservoir markers, currently being identified, in these same patients
Methodology
Pathophysiological study, in patients infected by multi drug-resistant viruses
Estimated enrollment
21 participants (total and per group)
Intervention
167mL blood sample in EDTA tube:
- 160mL (16 tubes of 10mL): for IGH (Institute of Human Genetics-Montpellier)
- 7mL (1tube of 7mL): to measure HIV-RNA in centers
Estimated planning or Study / Trial timetable
Study start date: September 2017
Enrollment period: 12 months
Total study duration: 24 months (analyses included)
Estimated study/trial completion date: September 2019 (one year after enrollment of the last patient)
Study design
Cross-sectional survey, 167mL of blood in EDTA tube will be obtained on a research visit, after signature of written informed consent
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Montpellier, France
- Monsef BENKIRANE
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who participated to ANRS139 TRIO trial, and still followed in centers
- Who remained in virological success since the participation at the trial: 90% of HIV-1 RNA level less than 50 copies/mL : one or more blips less than 1000 copies/mL are tolerated
- Genotypic resistance profiles available at baseline and before trial
- Age ≥ 18 years
- Affiliate or beneficiary of a social security system (the State Medical Aid or AME is not a social security system).
- Written informed consent signed by the person and the investigator before any exam performed in the study.
Exclusion Criteria:
- HIV-1 RNA level ≥ 1000 copies/mL at least once since the end of the 139 TRIO trial
- Patient participating in another research evaluating other treatments with an exclusion period ongoing at the screening visit.
- Person under legal guardianship or deprived of liberty by a judicial or administrative decision.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Presence of HIV viral sequences in the CD32 + CD4a + T lymphocytes of the patients
Time Frame: inclusion
|
inclusion
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANRS EP63 RESTA 32a
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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