Actively Recruiting
Accurate Staging of Immuno-virological Dynamics During Acute HIV Infection
Led by University Hospital, Ghent · Updated on 2025-01-14
70
Participants Needed
1
Research Sites
539 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Ghent
Lead Sponsor
V
ViiV Healthcare
Collaborating Sponsor
AI-Summary
What this Trial Is About
In this prospective longitudinal study we aim to assess how immunologic and viral aspects of the human immunodeficiency virus (HIV) viral reservoir, established during early HIV infection and responsible for viral rebound at treatment interruption, evolve in individuals who start combination anti-retroviral therapy (cART) during acute seroconversion. Recently infected patients will be selected based on Fiebig staging for an in depth sampling protocol at different timepoints during a 2 year follow up period. Colonbiopsies, lymphnode resection, lumbar puncture, leucapheresis and repeated peripheral venous blood-draws will be performed. Immunological, virological and genome expression analysis will be performed on the gathered samples.
CONDITIONS
Official Title
Accurate Staging of Immuno-virological Dynamics During Acute HIV Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented recent HIV-1 infection with early diagnosis based on clinical symptoms and incomplete Western Blot or recent negative screening test and incomplete Western Blot or risk contact within 3 months with presumable primo-infection
- Able and willing to provide written informed consent
- Ability to attend scheduled assessments and visits for either full or partial study participation
- Willingness to have blood and tissue samples collected, stored indefinitely, and used for research purposes
You will not qualify if you...
- Previous or current history of opportunistic infections defining AIDS or chronic HIV-1 infection
- Evidence of active Hepatitis B infection without seroconversion
- Evidence of active Hepatitis C infection confirmed by antibody or RNA test within 60 days prior to entry
- Current or known history of cardiomyopathy, significant ischemic or cerebrovascular disease
- Current history of cancer
- Pregnancy or breastfeeding
- Conditions that may interfere with study conduct or participant safety, including psychiatric or psychological disorders
- Previous participation in trials using immune modulating agents
- Abnormal lab results at screening: hemoglobin below 11 g/dl (women) or 12 g/dl (men), platelet count below 100,000/µl, neutrophil count below 1000/µl, or liver enzymes (AST/ALT) greater than 3 times upper limit
- Active drug or alcohol use or dependence affecting adherence
- Acute or serious illness requiring systemic treatment or hospitalization within 60 days prior to entry
AI-Screening
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Trial Site Locations
Total: 1 location
1
UZ Gent
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
Research Team
L
Linos Vandekerckhove, Prof. Dr.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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