Clinical trial NCT03940521: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV-1-infection
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: Institut de Génétique Moléculaire de Montpellier
First posted: 2019-05-07
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Percentage of CD4+ T cells expressing CD32 alone
timeFrame: Day 0
measure: Percentage of CD4+ T cells expressing X alone
timeFrame: Day 0
measure: Percentage of CD4+ T cells expressing both CD32 and X
timeFrame: Day 0
measure: Quantification of proviral load
timeFrame: Day 0
Secondary outcomes:
measure: Duration of infection prior to treatment
timeFrame: Day 0
measure: Duration of treatment
timeFrame: Day 0
measure: Year treatment commenced
timeFrame: Day 0
measure: Pre-therapeutic CD4 + T cell count
timeFrame: Day 0
measure: Pre-therapeutic viremia
timeFrame: Day 0
measure: Change in CD4+ T cells over previous 2 years
timeFrame: Day 0
measure: Change in CD4+ T cells prior to treatment
timeFrame: Day 0
measure: Change in CD4+ T cells during treatment
timeFrame: Day 0
measure: Viremia at inclusion into the study
timeFrame: Day 0
measure: Viremia during the 2 previous years
timeFrame: Day 0
measure: Residual immune activation at inclusion into the study
timeFrame: Day 0
measure: Residual immune activation during the previous 2 years
timeFrame: Day 0
measure: Nature of current treatment
timeFrame: Day 0
measure: Co-infection with hepatitis C virus
timeFrame: Day 0
measure: Co-infection with hepatitis B virus
timeFrame: Day 0
measure: Co-infection with Cytomegalovirus
timeFrame: Day 0
measure: Co-infection with Epstein-Barr virus
timeFrame: Day 0
measure: Testing for intact proviral DNA
timeFrame: Day 0
measure: Circulating viral RNA sequence
timeFrame: Day 0
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nimes
Study officials:
affiliation: CHU Nimes
name: Pierre Corbeau, MD
role: PRINCIPAL_INVESTIGATOR
References: