May 6, 2019
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May 7, 2019
|
January 27, 2021
|
September 30, 2020
|
June 2021 (Final data collection date for primary outcome measure)
|
|
Same as current
|
|
- 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
|
Same as current
|
Not Provided
|
Not Provided
|
|
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
|
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.
|
Not Provided
|
Observational
|
Observational Model: Case-Only Time Perspective: Prospective
|
Not Provided
|
Not Provided
|
Probability Sample
|
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.
|
HIV-1-infection
|
Other: Bioclinical evaluation
50-100ml blood extracted for flow cytometry and qPCR
|
HIV-A infected patients
Intervention: Other: Bioclinical evaluation
|
Not Provided
|
|
Recruiting
|
48
|
Same as current
|
June 2021
|
June 2021 (Final data collection date for primary outcome measure)
|
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
|
Sexes Eligible for Study: |
All |
|
18 Years and older (Adult, Older Adult)
|
No
|
Contact: Pierre Corbeau, MD |
0607231635 |
Pierre.corbeau@chu-nimes.fr |
|
|
France
|
|
|
NCT03940521
|
NIMAO/2018-02/PC-01
|
No
|
Studies a U.S. FDA-regulated Drug Product: |
No |
Studies a U.S. FDA-regulated Device Product: |
No |
|
|
Centre Hospitalier Universitaire de Nīmes
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Centre Hospitalier Universitaire de Nīmes
|
Institut de Génétique Moléculaire de Montpellier
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Principal Investigator: |
Pierre Corbeau, MD |
CHU Nimes |
|
Centre Hospitalier Universitaire de Nīmes
|
January 2021
|