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Bioclinical Evaluation of 2 Biomarkers of Aviremic HIV-1 in CD4+ T Cells of Adults Undergoing Treatment (RESERVIH32)

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ClinicalTrials.gov Identifier: NCT03940521
Recruitment Status : Not yet recruiting
First Posted : May 7, 2019
Last Update Posted : August 6, 2019
Sponsor:
Collaborator:
Institut de Génétique Moléculaire de Montpellier
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
HIV-1-infection Other: Bioclinical evaluation

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Study Type : Observational
Estimated Enrollment : 48 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Bioclinical Evaluation of 2 Biomarkers of Aviremic HIV-1 in CD4+ T Cells of Adults Undergoing Treatment
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
HIV-A infected patients Other: Bioclinical evaluation
50-100ml blood extracted for flow cytometry and qPCR




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940521


Contacts
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Contact: Pierre Corbeau, MD 0607231635 Pierre.corbeau@chu-nimes.fr

Locations
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France
CHU de Nimes Not yet recruiting
Nîmes, France, 30029
Contact: Anissa Megzari    04.66.68.42.36    drc@chu-nimes.fr   
Principal Investigator: Pierre Corbeau, MD         
Sub-Investigator: Claudine Barbuat, MD         
Sub-Investigator: Albert Sorro, MD         
Sub-Investigator: Jean-Marc Maulboussin, MD         
Sub-Investigator: Isabelle Rouanet, MD         
Sub-Investigator: Didier Laureillard, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Institut de Génétique Moléculaire de Montpellier
Investigators
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Principal Investigator: Pierre Corbeau, MD CHU Nimes

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03940521     History of Changes
Other Study ID Numbers: NIMAO/2018-02/PC-01
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No