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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)

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ClinicalTrials.gov Identifier: NCT03298360
Recruitment Status : Not yet recruiting
First Posted : October 2, 2017
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

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 Type : Observational
Estimated Enrollment : 21 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
Estimated Study Start Date : March 15, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS


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


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


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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.

Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT03298360     History of Changes
Other Study ID Numbers: ANRS EP63 RESTA 32a
First Posted: October 2, 2017    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
HIV cell reservoir

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases