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Active, Not Recruiting

NCT Number: NCT03940521

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nimes

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bioclinical evaluation

Other

50-100ml blood extracted for flow cytometry and qPCR

Primary outcomes

  1. Percentage of CD4+ T cells expressing CD32 alone

    Time frame: Day 0

    %

  2. Percentage of CD4+ T cells expressing X alone

    Time frame: Day 0

    %

  3. Percentage of CD4+ T cells expressing both CD32 and X

    Time frame: Day 0

    %

  4. Quantification of proviral load

    Time frame: Day 0

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

Secondary outcomes

  1. Duration of infection prior to treatment

    Time frame: Day 0

    Months

  2. Duration of treatment

    Time frame: Day 0

    Months

  3. Year treatment commenced

    Time frame: Day 0

    Year

  4. Pre-therapeutic CD4 + T cell count

    Time frame: Day 0

    Number of CD4+ T cells/ microL blood

  5. Pre-therapeutic viremia

    Time frame: Day 0

    Number of copies of HIV-1 RNA/ml plasma

  6. Change in CD4+ T cells over previous 2 years

    Time frame: Day 0

    Number of CD4+ T cells/microL blood lost per year

  7. Change in CD4+ T cells prior to treatment

    Time frame: Day 0

    Number of CD4+ T cells/microL blood lost per year

  8. Change in CD4+ T cells during treatment

    Time frame: Day 0

    Number of CD4+ T cells/microL blood lost per year

  9. Viremia at inclusion into the study

    Time frame: Day 0

    Number of copies of HIV-1 RNA/ml plasma

  10. Viremia during the 2 previous years

    Time frame: Day 0

    Number of copies of HIV-1 RNA/ml plasma

  11. Residual immune activation at inclusion into the study

    Time frame: Day 0

    CD4/CD8 ratio

  12. Residual immune activation during the previous 2 years

    Time frame: Day 0

    CD4/CD8 ratio

  13. Nature of current treatment

    Time frame: Day 0

    Family of molecule

  14. Co-infection with hepatitis C virus

    Time frame: Day 0

    Yes/No

  15. Co-infection with hepatitis B virus

    Time frame: Day 0

    Yes/No

  16. Co-infection with Cytomegalovirus

    Time frame: Day 0

    Yes/No

  17. Co-infection with Epstein-Barr virus

    Time frame: Day 0

    Yes/No

  18. Testing for intact proviral DNA

    Time frame: Day 0

    Number of copies/million cells

  19. Circulating viral RNA sequence

    Time frame: Day 0

    RNA sequence

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Collaborators

  • Institut de Génétique Moléculaire de Montpellier

Registry information

Acronym: RESERVIH32

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
May 7, 2019
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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