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

Completed

• Conditions: HIV Infections

• Registration Number: NCT03298360
• Lead Sponsor: ANRS, Emerging Infectious Diseases

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.

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 Timeline

• Study First Submitted: 2017-09-20
• Study First Submitted QC: 2017-09-29
• Study First Posted: 2017-10-02
• Study Start: 2018-06-28
• Primary Completion: 2019-06-25
• Study Completion: 2020-06-25
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-04
• Last Update Posted: 2020-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of HIV viral sequences in the CD32 + CD4a + T lymphocytes of the patients	inclusion

Trial Locations

Locations (1)

Monsef BENKIRANE; 🇫🇷 Montpellier, France