Immuno-virological Evaluation of Persons Living With HIV (PLWH)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Hospital, Ghent
About this trial
This is a dual arm (arm 1 and arm 2) multi-centric non-randomized (prospective) study.
Two new multicentric cohorts will be set up in 4 Belgian HIV reference centers (UZ Gent, UZ Brussel, University Hospital Liege and St. Pierre Hospital Brussels): cohort 1 will comprise PLWH in whom ART was initiated during acute HIV infection minimum 3 years ago but no more than 10 years ago (short-term ART cohort); cohort 2 will comprise PLWH on ART since \>20 years (long-term ART cohort). Participants will be included based on suppressed viremia and uninterrupted ART since initiation. Participants will undergo one blood sampling and one leukapheresis. In and exclusion criteria are described below.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Documented HIV-1 infection
Able and willing to provide written informed consent
Age = or >18 years and < 80 years
Clinical symptoms of acute seroconversion and incomplete Western Blot, or
Disqualifiers
Previous or current history of opportunistic infection (AIDS defining events as defined in category C of the Centers for Disease Control and Prevention (CDC) clinical classification), consisting of chronic HIV-1 infection.
Evidence of active Hepatitis B-virus (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.
Trial design
Design model
Single group
Treatments tested in this trial
Leucapheresis
Procedure/Surgeryleucapheresis is a procedure in which a large amount of blood cells are obtained by an apheresis procedure
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Immuno-virological evaluation of persons living with HIVExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Information on virological aspects of people on long term ART versus people treated during recent infection
Intact proviral deoxyribonucleic acid (DNA) assay quantified by digital Polymerase Chain Reaction (pcr)
Time frame
3 yearsSponsors and contacts
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University Hospital, Ghent
Lead sponsor
Vrije Universiteit Brussel
Collaborator
Centre Hospitalier Universitaire Saint Pierre
Collaborator
Centre Hospitalier Universitaire de Liege
Collaborator
Universitair Ziekenhuis Brussel
Collaborator
Université Libre de Bruxelles
Collaborator
KU Leuven
Collaborator
Source ClinicalTrials.gov