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

  • End date
    Jan 22, 2025
  • participants needed
  • sponsor
    University Hospital, Ghent
Updated on 22 March 2022
HIV Vaccine
Accepts healthy volunteers


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.

Condition Hiv
Clinical Study IdentifierNCT04653610
SponsorUniversity Hospital, Ghent
Last Modified on22 March 2022


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

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/µl
Confirmed neutrophil count <1000/μl
Confirmed AST and/or ALT > 10xULN
Active drug or alcohol use or dependence that, in the opinion of the site
Acute or serious illness, in the opinion of the site investigator, requiring systemic treatment and/or hospitalization within 60 days prior to entry
investigator, would interfere with adherence to study requirements
Known inflammatory bowel disease (Crohn's disease or ulcerative colitis)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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