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A Chronological Study of the Formation of HIV Cellular Reservoirs Through the Expression of Surface Markers on CD4 + T Lymphocytes, Including CD32a (ANRS EP63)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03298360
Recruitment Status : Completed
First Posted : October 2, 2017
Last Update Posted : December 8, 2020
Sponsor:
Information provided by (Responsible Party):
ANRS, Emerging Infectious Diseases

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
HIV Infections Other: Blood sample

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 Design
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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Other
Time Perspective: Other
Official Title: A Chronological Study of the Formation of HIV Cellular Reservoirs Through the Expression of Surface Markers on CD4 + T Lymphocytes, Including CD32a
Actual Study Start Date : June 28, 2018
Actual Primary Completion Date : June 25, 2019
Actual Study Completion Date : June 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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Intervention Details:
  • Other: Blood sample
    167mL of blood in EDTA tube will be obtained on a research visit, after signature of written informed consent

Outcome Measures
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Primary Outcome Measures :
  1. Presence of HIV viral sequences in the CD32 + CD4a + T lymphocytes of the patients [ Time Frame: inclusion ]

Eligibility Criteria
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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
Study Population
HIV Infection
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT03298360


Locations
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France
Monsef BENKIRANE
Montpellier, France
Sponsors and Collaborators
ANRS, Emerging Infectious Diseases
More Information
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Responsible Party: ANRS, Emerging Infectious Diseases
ClinicalTrials.gov Identifier: NCT03298360    
Other Study ID Numbers: ANRS EP63 RESTA 32a
First Posted: October 2, 2017    Key Record Dates
Last Update Posted: December 8, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ANRS, Emerging Infectious Diseases:
HIV cell reservoir
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases