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

NCT03940521 | Active Not Recruiting

• 1 other identifier: NIMAO/2018-02/PC-01
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (4)

• 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

• Quantification of proviral load

  Quantitative PCR; number of copies of HIV-1 DNA per million peripheral blood mononuclear cells

  Day 0

Secondary Outcomes (19)

• Duration of infection prior to treatment

  Day 0

• Duration of treatment

  Day 0

• Year treatment commenced

  Day 0

• Pre-therapeutic CD4 + T cell count

  Day 0

• Pre-therapeutic viremia

  Day 0

Study Arms (1)

HIV-A infected patients

Other: Bioclinical evaluation

Interventions

Bioclinical evaluation OTHER

50-100ml blood extracted for flow cytometry and qPCR

HIV-A infected patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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 must be a member or beneficiary of a health insurance plan
• Patient at least 18 years old

You may not qualify if:

• Patient has an acute infection
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead
• Institut de Génétique Moléculaire de Montpellier: collaborator

Study Sites (1)

CHU de Nimes

Nîmes, 30029, France

Location

Study Officials

• Pierre Corbeau, MD

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 7, 2019
• Study Start: September 30, 2020
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)