RESERVIH32: Bioclinical Evaluation of 2 Biomarkers of Aviremic HIV-1 in CD4+ T Cells of Adults Undergoing Treatment
Study Details
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 | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| HIV-A infected patients
|
Other: Bioclinical evaluation
50-100ml blood extracted for flow cytometry and qPCR
|
Outcome Measures
Primary Outcome Measures
- Percentage of CD4+ T cells expressing CD32 alone [Day 0]
- Percentage of CD4+ T cells expressing X alone [Day 0]
- Percentage of CD4+ T cells expressing both CD32 and X [Day 0]
- Quantification of proviral load [Day 0]
Quantitative PCR; number of copies of HIV-1 DNA per million peripheral blood mononuclear cells
Secondary Outcome Measures
- Duration of infection prior to treatment [Day 0]
Months
- Duration of treatment [Day 0]
Months
- Year treatment commenced [Day 0]
Year
- Pre-therapeutic CD4 + T cell count [Day 0]
Number of CD4+ T cells/ microL blood
- Pre-therapeutic viremia [Day 0]
Number of copies of HIV-1 RNA/ml plasma
- Change in CD4+ T cells over previous 2 years [Day 0]
Number of CD4+ T cells/microL blood lost per year
- Change in CD4+ T cells prior to treatment [Day 0]
Number of CD4+ T cells/microL blood lost per year
- Change in CD4+ T cells during treatment [Day 0]
Number of CD4+ T cells/microL blood lost per year
- Viremia at inclusion into the study [Day 0]
Number of copies of HIV-1 RNA/ml plasma
- Viremia during the 2 previous years [Day 0]
Number of copies of HIV-1 RNA/ml plasma
- Residual immune activation at inclusion into the study [Day 0]
CD4/CD8 ratio
- Residual immune activation during the previous 2 years [Day 0]
CD4/CD8 ratio
- Nature of current treatment [Day 0]
Family of molecule
- Co-infection with hepatitis C virus [Day 0]
Yes/No
- Co-infection with hepatitis B virus [Day 0]
Yes/No
- Co-infection with Cytomegalovirus [Day 0]
Yes/No
- Co-infection with Epstein-Barr virus [Day 0]
Yes/No
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de Nimes | Nîmes | France | 30029 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Nīmes
- Institut de Génétique Moléculaire de Montpellier
Investigators
- Principal Investigator: Pierre Corbeau, MD, CHU Nimes
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NIMAO/2018-02/PC-01