Phase
Condition
Hiv
Hiv/aids
Hiv Infections
Treatment
Early combination anti-retroviral treatment
Clinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Documented recent HIV-1 infection, early diagnosis: clinical symptoms of acuteseroconversion and incomplete Western Blot OR negative screening test within thepast 6 months and incomplete Western Blot OR risk contact within the 3 months andpresumable primo-infection with or without clinical symptoms and incomplete WesternBlot
Able and willing to provide written informed consent
Ability to attend the complete schedule of assessments and patient visits forpatients participating in option A schedule (described below), or ability to attenda partial schedule of assessments and patient visits for patients participating inoption B (described below).
Ability and willingness to have blood and tissue samples collected and storedindefinitely and used for various research purposes.
Exclusion
Exclusion Criteria:
Previous or current history of opportunistic infection (AIDS defining events asdefined in category C of the CDC clinical classification), consisting of chronicHIV-1 infection.
Evidence of active HBV infection (Hepatitis B surface antigen positive or HBV viralload positive in the past and no evidence of subsequent seroconversion (=HBV antigenor viral load negative and positive HBV surface antibody).
Evidence of active HCV infection: HCV antibody positive result within 60 days priorto study entry with positive HCV viral load or, if the HCV antibody result isnegative, a positive HCV RNA result within 60 days prior to study entry.
Current or known history of cardiomyopathy or significant ischemic orcerebrovascular disease.
Current history of cancer.
Pregnancy or breastfeeding.
Any conditions, including psychiatric and psychological disorders, which will in theopinion of the investigator interfere with the trial conduct or safety of theparticipant.
Previous participation in a trial evaluating an immune modulating agent
Abnormal laboratory tests results at screening: confirmed Hemoglobin <11g/dl forwomen and <12 g:dl for men/ confirmed platelet count < 100000/l / confirmedneutrophil count <1000/μl/ confirmed AST and/or ALT > 3xULN
Active drug or alcohol use or dependence that, in the opinion of the siteinvestigator, would interfere with adherence to study requirements.
Acute or serious illness, in the opinion of the site investigator, requiringsystemic treatment and/or hospitalization within 60 days prior to entry.
Study Design
Connect with a study center
UZ Gent
Gent, Oost-Vlaanderen 9000
BelgiumActive - Recruiting
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