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

Recruiting

• Conditions: HIV-1-infection
• Interventions: Other: Bioclinical evaluation

• Registration Number: NCT03940521
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-06
• Study First Submitted QC: 2019-05-06
• Study First Posted: 2019-05-07
• Study Start: 2020-09-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-16
• Primary Completion: 2025-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV-A infected patients	Bioclinical evaluation	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU de Nimes; 🇫🇷 Nîmes, France