Bioclinical Evaluation of 2 Biomarkers of Aviremic HIV-1 in CD4+ T Cells of Adults Undergoing Treatment (RESERVIH32)

The authors hypothesize that there is a correlation between the percentage of CD4+ T cells expressing CD32a and/or X and the quantity of DNA found in peripheral blood mononuclear cells in patients infected with HIV-1. Also, that there is a correlation between expression of CD32a and/or X and proviral load.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV-1-infection
• Intervention / Treatment: Other: Bioclinical evaluation

• Study Type: Observational
• Enrollment (Estimated): 48

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • CHU de Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with aviremic HIV-1 undergoing antiretroviral treatment for at least 2 years. Patients will be divided into 3 groups according to pre-therapeutic CD4+ T cell levels:

• "Low" (n=16): < 200 CD4+ T cells/mm3,
• "Medium" (n=16): 200 to 500 CD4+ T cells/mm3,
• "High" (n=16): >500 CD4+ T cells/mm3.

Description

Inclusion Criteria:

• Patient infected with aviremic HIV-1 (<20 copies of HIV-1 RNA/ml plasma) undergoing antiretroviral treatment for at least 2 years
• Patient has known duration of infection and treatment
• Patient has known pretherapeutic CD4+ T cell count and viremia
• Patient has known CD4+ T cell count, residual viremia and CD4/CD8 ratio for previous 2 years
• Patient weighs at least 56kg
• The patient is not opposed to their inclusion in the study
• The patient must be a member or beneficiary of a health insurance plan
• Patient at least 18 years old

Exclusion Criteria:

• Patient has an acute infection
• The subject has already been included in the study or is in a period of exclusion determined by a previous study
• It is impossible to give the subject informed information
• The patient is under safeguard of justice or state guardianship
• Patient is pregnant, parturient or breastfeeding

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HIV-A infected patients	Other: Bioclinical evaluation; 50-100ml blood extracted for flow cytometry and qPCR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantification of proviral load	Quantitative PCR; number of copies of HIV-1 DNA per million peripheral blood mononuclear cells	Day 0
Percentage of CD4+ T cells expressing CD32 alone	%	Day 0
Percentage of CD4+ T cells expressing X alone	%	Day 0
Percentage of CD4+ T cells expressing both CD32 and X	%	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of infection prior to treatment	Months	Day 0
Duration of treatment	Months	Day 0
Year treatment commenced	Year	Day 0
Pre-therapeutic CD4 + T cell count	Number of CD4+ T cells/ microL blood	Day 0
Pre-therapeutic viremia	Number of copies of HIV-1 RNA/ml plasma	Day 0
Change in CD4+ T cells over previous 2 years	Number of CD4+ T cells/microL blood lost per year	Day 0
Change in CD4+ T cells prior to treatment	Number of CD4+ T cells/microL blood lost per year	Day 0
Change in CD4+ T cells during treatment	Number of CD4+ T cells/microL blood lost per year	Day 0
Viremia at inclusion into the study	Number of copies of HIV-1 RNA/ml plasma	Day 0
Viremia during the 2 previous years	Number of copies of HIV-1 RNA/ml plasma	Day 0
Residual immune activation at inclusion into the study	CD4/CD8 ratio	Day 0
Residual immune activation during the previous 2 years	CD4/CD8 ratio	Day 0
Nature of current treatment	Family of molecule	Day 0
Co-infection with hepatitis C virus	Yes/No	Day 0
Co-infection with hepatitis B virus	Yes/No	Day 0
Co-infection with Cytomegalovirus	Yes/No	Day 0
Co-infection with Epstein-Barr virus	Yes/No	Day 0
Testing for intact proviral DNA	Number of copies/million cells	Day 0
Circulating viral RNA sequence	RNA sequence	Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Collaborators: Institut de Génétique Moléculaire de Montpellier
• Investigators: Principal Investigator: Pierre Corbeau, MD, CHU Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2020
• Primary Completion (Actual): September 30, 2025
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: May 6, 2019
• First Submitted That Met QC Criteria: May 6, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Estimated): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: NIMAO/2018-02/PC-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No