Actively Recruiting
Accurate Staging of Immune and Viral Changes During Acute HIV Infection A Prospective Longitudinal Study of Early Antiretroviral Treatment Effects
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
Researchers are studying how the immune system and viral characteristics of the HIV reservoir change over time in people who start combination anti-retroviral therapy (cART) during the early stage of HIV infection called acute seroconversion. This study focuses on recently infected individuals selected based on Fiebig staging, which helps identify the stage of early HIV infection. The purpose is to better understand the viral reservoir that causes the virus to rebound when treatment is stopped. Participants will begin early combination anti-retroviral treatment aimed at suppressing the HIV virus during acute seroconversion. The study includes two years of follow-up with detailed sampling at various time points. Procedures include colon biopsies, lymph node removal, lumbar punctures, leucapheresis, and repeated blood draws. The collected samples will be analyzed for immune, viral, and genetic information. During the study, participants will attend scheduled visits and assessments to provide samples and undergo evaluations. Researchers will monitor virological and immunological changes in the HIV reservoir over a total of 10 years. This includes observing the viral behavior and immune response after starting treatment early in infection. Safety and adherence will be closely followed throughout the study period.
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.
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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