Assessing immune and viral changes during early HIV infection
Accurate Staging of Immuno-virological Dynamics During Acute HIV Infection
This study is testing how the immune system and HIV levels change in people who start treatment right after getting HIV to help understand the virus better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital, Ghent Academic / other |
| Drugs / interventions | cART |
| Locations | 1 site (Ghent, Oost-Vlaanderen) |
| Trial ID | NCT03449706 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the immunologic and viral dynamics of the HIV reservoir in individuals who begin combination anti-retroviral therapy during acute seroconversion. Participants will be selected based on Fiebig staging and will undergo a series of procedures, including biopsies and blood draws, over a two-year follow-up period. The study will analyze samples for immunological, virological, and gene expression changes to better understand the evolution of the viral reservoir.
Who should consider this trial
Good fit: Ideal candidates are individuals with documented recent HIV-1 infection and acute seroconversion symptoms.
Not a fit: Patients with a history of opportunistic infections or those who cannot provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for managing HIV and potentially reducing viral rebound after treatment interruption.
How similar studies have performed: While there have been studies on HIV dynamics, this specific approach focusing on early treatment and the viral reservoir is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Documented recent HIV-1 infection, early diagnosis: clinical symptoms of acute seroconversion and incomplete Western Blot OR negative screening test within the past 6 months and incomplete Western Blot OR risk contact within the 3 months and presumable primo-infection with or without clinical symptoms and incomplete Western Blot * Able and willing to provide written informed consent * Ability to attend the complete schedule of assessments and patient visits for patients participating in option A schedule (described below), or ability to attend a partial schedule of assessments and patient visits for patients participating in option B (described below). * Ability and willingness to have blood and tissue samples collected and stored indefinitely and used for various research purposes. Exclusion Criteria: * Previous or current history of opportunistic infection (AIDS defining events as defined in category C of the CDC clinical classification), consisting of chronic HIV-1 infection. * Evidence of active HBV infection (Hepatitis B surface antigen positive or HBV viral load positive in the past and no evidence of subsequent seroconversion (=HBV antigen or viral load negative and positive HBV surface antibody). * Evidence of active HCV infection: HCV antibody positive result within 60 days prior to study entry with positive HCV viral load or, if the HCV antibody result is negative, a positive HCV RNA result within 60 days prior to study entry. * Current or known history of cardiomyopathy or significant ischemic or cerebrovascular disease. * Current history of cancer. * Pregnancy or breastfeeding. * Any conditions, including psychiatric and psychological disorders, which will in the opinion of the investigator interfere with the trial conduct or safety of the participant. * Previous participation in a trial evaluating an immune modulating agent * Abnormal laboratory tests results at screening: confirmed Hemoglobin \<11g/dl for women and \<12 g:dl for men/ confirmed platelet count \< 100000/l / confirmed neutrophil count \<1000/μl/ confirmed AST and/or ALT \> 3xULN * Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. * Acute or serious illness, in the opinion of the site investigator, requiring systemic treatment and/or hospitalization within 60 days prior to entry.
Where this trial is running
Ghent, Oost-Vlaanderen
- UZ Gent — Ghent, Oost-Vlaanderen, Belgium (Recruiting)
Study contacts
- Principal investigator: Linos Vandekerckhove, Prof. Dr. — University Hospital, Ghent
- Study coordinator: Linos Vandekerckhove, Prof. Dr.
- Email: linos.vandekerckhove@ugent.be
- Phone: +3293323398
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.