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出境医 / 临床实验 / Bioclinical Evaluation of 2 Biomarkers of Aviremic HIV-1 in CD4+ T Cells of Adults Undergoing Treatment (RESERVIH32)

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

Study Description
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

Study Design
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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
Actual Study Start Date : September 30, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021
Arms and Interventions
Group/Cohort Intervention/treatment
HIV-A infected patients Other: Bioclinical evaluation
50-100ml blood extracted for flow cytometry and qPCR
Outcome Measures
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


Eligibility Criteria
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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
Contacts and Locations

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

Locations
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France
CHU de Nimes 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
Layout table for investigator information
Principal Investigator: Pierre Corbeau, MD CHU Nimes
Tracking Information
First Submitted Date May 6, 2019
First Posted Date May 7, 2019
Last Update Posted Date January 27, 2021
Actual Study Start Date September 30, 2020
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 6, 2019)
  • Percentage of CD4+ T cells expressing CD32 alone [ Time Frame: Day 0 ]
  • Percentage of CD4+ T cells expressing X alone [ Time Frame: Day 0 ]
  • Percentage of CD4+ T cells expressing both CD32 and X [ Time Frame: Day 0 ]
  • Quantification of proviral load [ Time Frame: Day 0 ]
    Quantitative PCR; number of copies of HIV-1 DNA per million peripheral blood mononuclear cells
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 6, 2019)
  • Duration of infection prior to treatment [ Time Frame: Day 0 ]
    Months
  • Duration of treatment [ Time Frame: Day 0 ]
    Months
  • Year treatment commenced [ Time Frame: Day 0 ]
    Year
  • Pre-therapeutic CD4 + T cell count [ Time Frame: Day 0 ]
    Number of CD4+ T cells/ microL blood
  • Pre-therapeutic viremia [ Time Frame: Day 0 ]
    Number of copies of HIV-1 RNA/ml plasma
  • Change in CD4+ T cells over previous 2 years [ Time Frame: Day 0 ]
    Number of CD4+ T cells/microL blood lost per year
  • Change in CD4+ T cells prior to treatment [ Time Frame: Day 0 ]
    Number of CD4+ T cells/microL blood lost per year
  • Change in CD4+ T cells during treatment [ Time Frame: Day 0 ]
    Number of CD4+ T cells/microL blood lost per year
  • Viremia at inclusion into the study [ Time Frame: Day 0 ]
    Number of copies of HIV-1 RNA/ml plasma
  • Viremia during the 2 previous years [ Time Frame: Day 0 ]
    Number of copies of HIV-1 RNA/ml plasma
  • Residual immune activation at inclusion into the study [ Time Frame: Day 0 ]
    CD4/CD8 ratio
  • Residual immune activation during the previous 2 years [ Time Frame: Day 0 ]
    CD4/CD8 ratio
  • Nature of current treatment [ Time Frame: Day 0 ]
    Family of molecule
  • Co-infection with hepatitis C virus [ Time Frame: Day 0 ]
    Yes/No
  • Co-infection with hepatitis B virus [ Time Frame: Day 0 ]
    Yes/No
  • Co-infection with Cytomegalovirus [ Time Frame: Day 0 ]
    Yes/No
  • Co-infection with Epstein-Barr virus [ Time Frame: Day 0 ]
    Yes/No
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Bioclinical Evaluation of 2 Biomarkers of Aviremic HIV-1 in CD4+ T Cells of Adults Undergoing Treatment
Official Title Bioclinical Evaluation of 2 Biomarkers of Aviremic HIV-1 in CD4+ T Cells of Adults Undergoing Treatment
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 Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition HIV-1-infection
Intervention Other: Bioclinical evaluation
50-100ml blood extracted for flow cytometry and qPCR
Study Groups/Cohorts HIV-A infected patients
Intervention: Other: Bioclinical evaluation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 6, 2019) 		48
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pierre Corbeau, MD 0607231635 Pierre.corbeau@chu-nimes.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03940521
Other Study ID Numbers NIMAO/2018-02/PC-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire de Nīmes
Study Sponsor Centre Hospitalier Universitaire de Nīmes
Collaborators Institut de Génétique Moléculaire de Montpellier
Investigators
Principal Investigator: Pierre Corbeau, MD CHU Nimes
PRS Account Centre Hospitalier Universitaire de Nīmes
Verification Date January 2021

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