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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03940521
Acronym
RESERVIH32
Enrollment
48
Registered
2019-05-07
Start date
2020-09-30
Completion date
2026-09-30
Last updated
2025-11-17

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

Conditions

HIV-1-infection

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.

Interventions

OTHERBioclinical evaluation

50-100ml blood extracted for flow cytometry and qPCR

Sponsors

Institut de Génétique Moléculaire de Montpellier
CollaboratorOTHER
Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of CD4+ T cells expressing CD32 aloneDay 0%
Percentage of CD4+ T cells expressing X aloneDay 0%
Percentage of CD4+ T cells expressing both CD32 and XDay 0%
Quantification of proviral loadDay 0Quantitative PCR; number of copies of HIV-1 DNA per million peripheral blood mononuclear cells

Secondary

MeasureTime frameDescription
Pre-therapeutic viremiaDay 0Number of copies of HIV-1 RNA/ml plasma
Change in CD4+ T cells over previous 2 yearsDay 0Number of CD4+ T cells/microL blood lost per year
Change in CD4+ T cells prior to treatmentDay 0Number of CD4+ T cells/microL blood lost per year
Change in CD4+ T cells during treatmentDay 0Number of CD4+ T cells/microL blood lost per year
Viremia at inclusion into the studyDay 0Number of copies of HIV-1 RNA/ml plasma
Viremia during the 2 previous yearsDay 0Number of copies of HIV-1 RNA/ml plasma
Residual immune activation at inclusion into the studyDay 0CD4/CD8 ratio
Duration of infection prior to treatmentDay 0Months
Nature of current treatmentDay 0Family of molecule
Co-infection with hepatitis C virusDay 0Yes/No
Co-infection with hepatitis B virusDay 0Yes/No
Co-infection with CytomegalovirusDay 0Yes/No
Co-infection with Epstein-Barr virusDay 0Yes/No
Testing for intact proviral DNADay 0Number of copies/million cells
Circulating viral RNA sequenceDay 0RNA sequence
Residual immune activation during the previous 2 yearsDay 0CD4/CD8 ratio
Duration of treatmentDay 0Months
Year treatment commencedDay 0Year
Pre-therapeutic CD4 + T cell countDay 0Number of CD4+ T cells/ microL blood

Countries

France

Outcome results

None listed

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