HIV Study on MEasuring the Reservoir on Cellular Level to CUre Infection

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    25
  • sponsor
    University Hospital, Ghent
Updated on 16 July 2021
HIV Vaccine

Summary

The aim of this study is to gain new insights into HIV latency and reversal through extensive blood and tissues sampling (lymph node and colon biopsies) from 25 individuals under ART.

Details
Condition HIV, HIV positive, HIV infection, AIDS Vaccines, HIV Infections, human immunodeficiency virus, hiv disease, HIV Vaccine, hiv vaccines
Clinical Study IdentifierNCT04305665
SponsorUniversity Hospital, Ghent
Last Modified on16 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Documented HIV-1 subtype B infection
Able and willing to provide written informed consent
Age = or >18 years and < 65 years
CD4 count at screening > 350/l
Viral load < 40 copies/ml determined by CobasTaqMan HIV-1 test v2.0 assay for at least 2 years (one blip < 200 copies/ml is allowed)
Ability and willingness to have blood and tissue samples collected and stored for 20 years and used for various research purposes

Exclusion Criteria

Previous or current history of opportunistic infection (AIDS defining events as defined in category C of the CDC clinical classification), consisting of chronic HIV-1 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
History of HIV-related thrombocytopenia
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 results of standard of care laboratory tests
Confirmed haemoglobin <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
The following treatment will be prohibited three months before screening and during the study
immunosuppressive drugs (inclusive corticosteroids) except for drugs used for topical use
Immunomodulatory drugs including but not limited to Granulocyte-colony stimulating factors, Granulocyte-monocyte colony-stimulating factor, interleukin 2, 7 & 15\
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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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