Accurate Staging of Immuno-virological Dynamics During Acute HIV Infection (NCT03449706) | Clinical Trial Compass
RecruitingNot Applicable
Accurate Staging of Immuno-virological Dynamics During Acute HIV Infection
Belgium70 participantsStarted 2017-09-01
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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 k…
What they're measuring
1
Evolution of virological and immunological parameters of the HIV reservoir in recently infected HIV positive patients that started treatment during acute seroconversion.