Assessing immune and viral changes during early HIV infection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.