Sequential Analysis Before and After Treatment Initiation to Unravel the Role of Naturally Occurring Extracellular Vesicles in HIV Infection

  • STATUS
    Recruiting
  • End date
    Jan 11, 2025
  • participants needed
    66
  • sponsor
    University Hospital, Ghent
Updated on 11 June 2021
HIV Vaccine

Summary

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.

Details
Condition HIV, HIV positive, HIV infection, AIDS Vaccines, HIV Infections, human immunodeficiency virus, hiv disease, HIV Vaccine, hiv vaccines
Clinical Study IdentifierNCT04653610
SponsorUniversity Hospital, Ghent
Last Modified on11 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Able and willing to provide written informed consent
Age 18 years and 65 years
Ability to attend the complete sampling schedule, as described below
Ability and willingness to have blood, stool and colon samples collected and stored for 20 years and used for various research purposes

Exclusion Criteria

HIV-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 or known history of cancer
Pregnancy or breastfeeding
Any conditions, including preexisting 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 < 100 000/l
Confirmed neutrophil count <1000/l
Confirmed AST and/or ALT > 10xULN
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
Known inflammatory bowel disease (Crohn's disease or ulcerative colitis)
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