Accurate Staging of Immuno-virological Dynamics During Acute HIV Infection (ACS)
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|ClinicalTrials.gov Identifier: NCT03449706|
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : February 21, 2020
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.
|Condition or disease||Intervention/treatment|
|HIV Seroconversion, HIV||Drug: Early combination anti-retroviral treatment|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Accurate Staging of Immuno-virological Dynamics During Acute HIV Infection|
|Actual Study Start Date :||September 1, 2017|
|Estimated Primary Completion Date :||January 1, 2023|
|Estimated Study Completion Date :||January 1, 2023|
- Drug: Early combination anti-retroviral treatment
Patients are started on treatment to supress the HIV virus in the phase of acute seroconversion.
- Evolution of virological and immunological parameters of the HIV reservoir in recently infected HIV positive patients that started treatment during acute seroconversion. [ Time Frame: 10 years ]Virological, immunological and gene expression analysis on blood and tissue from in depth sampling.
- Evolution of microbiome in recently infected HIV positive patients that started treatment during acute seroconversion. [ Time Frame: 10 years ]Microbiome analysis on stoolsamples.
Biospecimen Retention: Samples With DNA
- Colon biopsy
- Lymphnode biopsy
- Cerebrospinal fluids
- Whole blood
- Leucapheresis apherate
- Cervicovaginal liquid
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03449706
|Contact: Linos Vandekerckhove, Prof. Dr.||+firstname.lastname@example.org|
|Gent, Oost-Vlaanderen, Belgium, 9000|
|Contact: Linos Vandekerckhove, Prof. Dr. +3293323398 email@example.com|
|Principal Investigator: Linos Vandekerckhove, Prof.|
|Principal Investigator:||Linos Vandekerckhove, Prof. Dr.||University Hospital, Ghent|