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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03298360
Acronym
ANRS EP63
Enrollment
11
Registered
2017-10-02
Start date
2018-06-28
Completion date
2020-06-25
Last updated
2020-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV cell reservoir

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

Interventions

OTHERBlood sample

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

Sponsors

ANRS, Emerging Infectious Diseases
Lead SponsorOTHER_GOV

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Presence of HIV viral sequences in the CD32 + CD4a + T lymphocytes of the patientsinclusion

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026