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

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV-1-infection

Intervention / Treatment
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* Other: Bioclinical evaluation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV-A infected patients<br> | Other: Bioclinical evaluation<br>* 50-100ml blood extracted for flow cytometry and qPCR<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Quantitative PCR; number of copies of HIV-1 DNA per million peripheral blood mononuclear cells | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of infection prior to treatment | Months | Day 0 | 
| Duration of treatment | Months | Day 0 | 
| Year treatment commenced | Year | Day 0 | 
| Pre-therapeutic CD4 + T cell count | Number of CD4+ T cells/ microL blood | Day 0 | 
| Pre-therapeutic viremia | Number of copies of HIV-1 RNA/ml plasma | Day 0 | 
| Change in CD4+ T cells over previous 2 years | Number of CD4+ T cells/microL blood lost per year | Day 0 | 
| Change in CD4+ T cells prior to treatment | Number of CD4+ T cells/microL blood lost per year | Day 0 | 
| Change in CD4+ T cells during treatment | Number of CD4+ T cells/microL blood lost per year | Day 0 | 
| Viremia at inclusion into the study | Number of copies of HIV-1 RNA/ml plasma | Day 0 | 
| Viremia during the 2 previous years | Number of copies of HIV-1 RNA/ml plasma | Day 0 | 
| Residual immune activation at inclusion into the study | CD4/CD8 ratio | Day 0 | 
| Residual immune activation during the previous 2 years | CD4/CD8 ratio | Day 0 | 
| Nature of current treatment | Family of molecule | Day 0 | 
| Co-infection with hepatitis C virus | Yes/No | Day 0 | 
| Co-infection with hepatitis B virus | Yes/No | Day 0 | 
| Co-infection with Cytomegalovirus | Yes/No | Day 0 | 
| Co-infection with Epstein-Barr virus | Yes/No | Day 0 | 
| Testing for intact proviral DNA | Number of copies/million cells | Day 0 | 
| Circulating viral RNA sequence | RNA sequence | Day 0 |