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

HIV-1-infection Clinical Trial

— RESERVIH32  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03940521
• Other study ID #: NIMAO/2018-02/PC-01
• Status: Recruiting
• Start date: September 30, 2020
• Est. completion date: September 2025

Study information

• Verified date: September 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Pierre Corbeau, MD
• Phone: 0607231635
• Email: Pierre.corbeau[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: September 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV-1-infection

Intervention

Other:
• Bioclinical evaluation
50-100ml blood extracted for flow cytometry and qPCR

Locations

Country	Name	City	State
France	CHU de Nimes	Nîmes

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes	Institut de Génétique Moléculaire de Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of CD4+ T cells expressing CD32 alone		Day 0
Primary	Percentage of CD4+ T cells expressing X alone		Day 0
Primary	Percentage of CD4+ T cells expressing both CD32 and X		Day 0
Primary	Quantification of proviral load	Quantitative PCR; number of copies of HIV-1 DNA per million peripheral blood mononuclear cells	Day 0
Secondary	Duration of infection prior to treatment	Months	Day 0
Secondary	Duration of treatment	Months	Day 0
Secondary	Year treatment commenced	Year	Day 0
Secondary	Pre-therapeutic CD4 + T cell count	Number of CD4+ T cells/ microL blood	Day 0
Secondary	Pre-therapeutic viremia	Number of copies of HIV-1 RNA/ml plasma	Day 0
Secondary	Change in CD4+ T cells over previous 2 years	Number of CD4+ T cells/microL blood lost per year	Day 0
Secondary	Change in CD4+ T cells prior to treatment	Number of CD4+ T cells/microL blood lost per year	Day 0
Secondary	Change in CD4+ T cells during treatment	Number of CD4+ T cells/microL blood lost per year	Day 0
Secondary	Viremia at inclusion into the study	Number of copies of HIV-1 RNA/ml plasma	Day 0
Secondary	Viremia during the 2 previous years	Number of copies of HIV-1 RNA/ml plasma	Day 0
Secondary	Residual immune activation at inclusion into the study	CD4/CD8 ratio	Day 0
Secondary	Residual immune activation during the previous 2 years	CD4/CD8 ratio	Day 0
Secondary	Nature of current treatment	Family of molecule	Day 0
Secondary	Co-infection with hepatitis C virus	Yes/No	Day 0
Secondary	Co-infection with hepatitis B virus	Yes/No	Day 0
Secondary	Co-infection with Cytomegalovirus	Yes/No	Day 0
Secondary	Co-infection with Epstein-Barr virus	Yes/No	Day 0
Secondary	Testing for intact proviral DNA	Number of copies/million cells	Day 0
Secondary	Circulating viral RNA sequence	RNA sequence	Day 0