Actively Recruiting
Sequential Analysis Before and After Treatment Initiation to Unravel the Role of Naturally Occurring Extracellular Vesicles in HIV Infection
Led by University Hospital, Ghent · Updated on 2024-02-08
105
Participants Needed
1
Research Sites
309 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the role of extracellular vesicles in HIV-infection, by determining the expression profile and content of EVs before and after treatment initiation in HIV-infected patients, through extensive blood and tissue sampling (leukapheresis, stool sampling and colon biopsies). A one-time sampling (blood, stool, colon biopsies) will also be performed in HIV-seronegative healthy volunteers to confirm that results found in HIV-infected patients are related to the disease.
CONDITIONS
Official Title
Sequential Analysis Before and After Treatment Initiation to Unravel the Role of Naturally Occurring Extracellular Vesicles in HIV Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented untreated HIV-1 infection confirmed by HIV-1-specific antibody and p31+ test
- CD4 T cell count either below 350 cells/µl or above 350 cells/µl (minimum 16 patients in each group)
- Age between 18 and 65 years
- Able and willing to provide written informed consent
- Able to attend all study visits and assessments
- Willing to have blood, stool, and colon samples collected and stored for 20 years for research
- For healthy volunteers: age between 18 and 65, able to consent, attend sampling schedule, and provide samples for storage
You will not qualify if you...
- Recent or early HIV diagnosis
- Past or current opportunistic infections related to chronic HIV-1 infection
- Active Hepatitis B infection or no seroconversion after past infection
- Active Hepatitis C infection within 60 days prior to study entry
- History of cardiomyopathy, significant ischemic or cerebrovascular disease
- Current or past cancer
- Pregnancy or breastfeeding
- Psychiatric or psychological disorders interfering with study conduct or safety
- Previous participation in trials with immune modulating agents
- Abnormal lab results at screening (low hemoglobin, platelet, neutrophil counts, or high liver enzymes)
- Active drug or alcohol use interfering with study adherence
- Acute or serious illness requiring treatment or hospitalization within 60 days prior
- Known inflammatory bowel disease such as Crohn's disease or ulcerative colitis
- For healthy volunteers: HIV infection or any above exclusion criteria
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ghent University Hospital
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
2
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