NCT03449706 Accurate Staging of Immuno-virological Dynamics During Acute HIV Infection
| NCT ID | NCT03449706 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Ghent |
| Condition | HIV |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2017-09-01 |
| Primary Completion | 2028-01-01 |
Trial Parameters
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Brief Summary
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
Inclusion Criteria: * 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. 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 H
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