Evaluating biomarkers in HIV-1 infected adults on treatment
Bioclinical Evaluation of 2 Biomarkers of Aviremic HIV-1 in CD4+ T Cells of Adults Undergoing Treatment
This study is testing if certain markers in the blood can help doctors better understand HIV-1 levels in adults who have been on treatment for at least two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Locations | 1 site (Nîmes) |
| Trial ID | NCT03940521 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationship between specific biomarkers, CD32a and/or X, in CD4+ T cells and the levels of HIV-1 DNA in the blood of adults who have been on antiretroviral treatment for at least two years. The researchers will analyze the correlation between these biomarkers and the proviral load in patients with aviremic HIV-1 infection. By understanding these relationships, the study seeks to enhance the clinical management of HIV-1 infection.
Who should consider this trial
Good fit: Ideal candidates are adults infected with aviremic HIV-1 who have been on antiretroviral treatment for at least two years.
Not a fit: Patients with acute infections or those who are pregnant, parturient, or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and treatment strategies for patients living with HIV-1.
How similar studies have performed: While this approach is based on established biomarkers, the specific correlations being studied have not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nîmes
- CHU de Nimes — Nîmes, France (Recruiting)
Study contacts
- Principal investigator: Pierre Corbeau, MD — CHU Nimes
- Study coordinator: Pierre Corbeau, MD
- Email: Pierre.corbeau@chu-nimes.fr
- Phone: 0607231635
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.