Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome
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StatusCompleted
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
University Hospital Tuebingen
Albert Schweitzer Hospital
CLINICAL TRIAL: NCT01557803
BioSeek: NCT01557803
Keywords
Abstract
The objective of this project is to determine clinical and biological predictors of Immune Reconstitution Inflammatory Syndrome (IRIS) occurrence in HIV infected patients who are started on antiretroviral therapy (ART), and to obtain more insight into the pathogenesis of this syndrome. The investigators will prospectively study HIV infected patients in Sub Saharan Africa who will be initiated on ART and are at risk to develop IRIS in all its different appearances. In these patients, the investigators will assess the value of clinical features and plasma biomarkers to predict IRIS, and the investigators will obtain insight into which inflammatory pathways become activated during IRIS. This project will provide novel knowledge about this clinically highly relevant healthcare problem in a resource poor setting, namely in Lambaréné, Gabon, in the Central African rainforest belt. In Gabon little research has been done in the field of HIV. The epidemiological pattern of IRIS in Gabon will be described. Promising putative plasma biomarkers will be validated for their use in daily practice.
Dates
| Last Verified: | 12/31/2014 |
| First Submitted: | 03/15/2012 |
| Estimated Enrollment Submitted: | 03/18/2012 |
| First Posted: | 03/19/2012 |
| Last Update Submitted: | 01/12/2015 |
| Last Update Posted: | 01/13/2015 |
| Actual Study Start Date: | 12/31/2011 |
| Estimated Primary Completion Date: | 01/31/2014 |
| Estimated Study Completion Date: | 12/31/2014 |
Condition or disease
Immune Reconstitution Inflammatory Syndrome
Opportunistic Infections
Phase
-
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Starting ART Adult patients starting anti retroviral therapy for the first time |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Sampling method | Non-Probability Sample |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Age > 18 years - Informed consent - ART naive Exclusion Criteria: - No informed consent - History of ART use - Pregnancy |
Outcome
Primary Outcome Measures
1. IRIS [12 months]
Development of immune reconstitution inflammatory syndrome
Secondary Outcome Measures
1. Time to IRIS [12 months]
Time to development of immune reconstitution inflammatory syndrome
