Accurate Staging of Immuno-virological Dynamics During Acute HIV Infection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUniversity Hospital, Ghent
About this trial
In this prospective longitudinal study we aim to assess how immunologic and viral aspects of the human immunodeficiency virus (HIV) viral reservoir, established during early HIV infection and responsible for viral rebound at treatment interruption, evolve in individuals who start combination anti-retroviral therapy (cART) during acute seroconversion.
Recently infected patients will be selected based on Fiebig staging for an in depth sampling protocol at different timepoints during a 2 year follow up period. Colonbiopsies, lymphnode resection, lumbar puncture, leucapheresis and repeated peripheral venous blood-draws will be performed. Immunological, virological and genome expression analysis will be performed on the gathered samples.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Documented recent HIV-1 infection, early diagnosis: clinical symptoms of acute seroconversion and incomplete Western Blot OR negative screening test within the past 6 months and incomplete Western Blot OR risk contact within the 3 months and presumable primo-infection with or without clinical symptoms and incomplete Western Blot
Able and willing to provide written informed consent
Ability to attend the complete schedule of assessments and patient visits for patients participating in option A schedule (described below), or ability to attend a partial schedule of assessments and patient visits for patients participating in option B (described below).
Ability and willingness to have blood and tissue samples collected and stored indefinitely and used for various research purposes.
Disqualifiers
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.
Trial population
We will enroll a minimum of 30 patients and a maximum of 70 participants (Fiebig stages I - VI) in the study to establish a cohort of early treated patients. We aim at including at least 15 people with an incomplete Western Blot (Fiebig I-\>IV) and as a control we will also include patients with complete Western Blot and history of a semi-recent infection (Fiebig V-VI).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Early combination anti-retroviral treatment
DrugPatients are started on treatment to supress the HIV virus in the phase of acute seroconversion.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Evolution of virological and immunological parameters of the HIV reservoir in recently infected HIV positive patients that started treatment during acute seroconversion.
Virological, immunological and gene expression analysis on blood and tissue from in depth sampling.
Time frame
10 yearsSecondary outcomes
1
Evolution of microbiome in recently infected HIV positive patients that started treatment during acute seroconversion.
Microbiome analysis on stoolsamples.
Time frame
10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Ghent
Lead sponsor
ViiV Healthcare
Collaborator
Source ClinicalTrials.gov