HIV-1-infection Clinical Trial
— RESERVIH32Official title:
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.
Status | Recruiting |
Enrollment | 48 |
Est. completion date | September 2025 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU de Nimes | Nîmes |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nimes | Institut de Génétique Moléculaire de Montpellier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of CD4+ T cells expressing CD32 alone | Day 0 | ||
Primary | Percentage of CD4+ T cells expressing X alone | Day 0 | ||
Primary | Percentage of CD4+ T cells expressing both CD32 and X | Day 0 | ||
Primary | Quantification of proviral load | Quantitative PCR; number of copies of HIV-1 DNA per million peripheral blood mononuclear cells | Day 0 | |
Secondary | Duration of infection prior to treatment | Months | Day 0 | |
Secondary | Duration of treatment | Months | Day 0 | |
Secondary | Year treatment commenced | Year | Day 0 | |
Secondary | Pre-therapeutic CD4 + T cell count | Number of CD4+ T cells/ microL blood | Day 0 | |
Secondary | Pre-therapeutic viremia | Number of copies of HIV-1 RNA/ml plasma | Day 0 | |
Secondary | Change in CD4+ T cells over previous 2 years | Number of CD4+ T cells/microL blood lost per year | Day 0 | |
Secondary | Change in CD4+ T cells prior to treatment | Number of CD4+ T cells/microL blood lost per year | Day 0 | |
Secondary | Change in CD4+ T cells during treatment | Number of CD4+ T cells/microL blood lost per year | Day 0 | |
Secondary | Viremia at inclusion into the study | Number of copies of HIV-1 RNA/ml plasma | Day 0 | |
Secondary | Viremia during the 2 previous years | Number of copies of HIV-1 RNA/ml plasma | Day 0 | |
Secondary | Residual immune activation at inclusion into the study | CD4/CD8 ratio | Day 0 | |
Secondary | Residual immune activation during the previous 2 years | CD4/CD8 ratio | Day 0 | |
Secondary | Nature of current treatment | Family of molecule | Day 0 | |
Secondary | Co-infection with hepatitis C virus | Yes/No | Day 0 | |
Secondary | Co-infection with hepatitis B virus | Yes/No | Day 0 | |
Secondary | Co-infection with Cytomegalovirus | Yes/No | Day 0 | |
Secondary | Co-infection with Epstein-Barr virus | Yes/No | Day 0 | |
Secondary | Testing for intact proviral DNA | Number of copies/million cells | Day 0 | |
Secondary | Circulating viral RNA sequence | RNA sequence | Day 0 |
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