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

HIV Infections Clinical Trial

— ANRS EP63  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03298360
• Other study ID #: ANRS EP63 RESTA 32a
• Status: Completed
• Start date: June 28, 2018
• Est. completion date: June 25, 2020

Study information

• Verified date: December 2020
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 25, 2020
• Est. primary completion date: June 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

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

Locations

Country	Name	City	State
France	Monsef BENKIRANE	Montpellier

Sponsors (1)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of HIV viral sequences in the CD32 + CD4a + T lymphocytes of the patients		inclusion