Clinical Trials

MainTitle

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

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified September 2017 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Sponsor
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)


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)
ClinicalTrials.gov Identifier
NCT03298360

First received: September 20, 2017
Last updated: October 31, 2017
Last Verified: September 2017
History of Changes
Purpose

Purpose

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 Intervention
HIV Infections

Other : Blood sample

Study Type: Observational
Study Design: 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

Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures

  • Presence of HIV viral sequences in the CD32 + CD4a + T lymphocytes of the patients [ Time Frame: inclusion ]

Estimated Enrollment: 21
Study Start Date: November 15, 2017
Estimated Study Completion Date: September 1, 2019
Estimated Primary Completion Date: September 1, 2018 (Final data collection date for primary outcome measure)

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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03298360

Sponsors and Collaborators

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
More Information

More Information


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  
Study First Received: September 20, 2017  
Last Updated: October 31, 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

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.