Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome (IRIS)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Immune Reconstitution Inflammatory Syndrome Opportunistic Infections |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
Plasma, Paxgene RNA tubes and urine
| Estimated Enrollment: | 200 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Starting ART
Adult patients starting anti retroviral therapy for the first time
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Adult HIV patients starting anti retroviral therapy for the first time
Inclusion Criteria:
- Age > 18 years
- Informed consent
- ART naive
Exclusion Criteria:
- No informed consent
- History of ART use
- Pregnancy
Contacts and Locations| Contact: Saskia Janssen, MD | 0031641283621 | S.Janssen@amc.uva.nl |
| Contact: Martin Peter Grobusch, MD, MSc, DTM&H | 00316205664380 | M.P.Grobusch@amc.uva.nl |
| Gabon | |
| Medical Research Unit - Albert Schweitzer Hospital | Recruiting |
| Lambaréné, Moyen Ogoué, Gabon, BP118 | |
| Contact: Saskia Janssen, MD 0024106538454 S.Janssen@amc.uva.nl | |
| Contact: MP Grobusch, MD, MSc, DTM&H 0031205664380 M.P.Grobusch@amc.uva.nl | |
| Study Chair: | MP Grobusch, MD, MSc, DTM&H | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
More Information
No publications provided
| Responsible Party: | S. Janssen, MD, MSc, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| ClinicalTrials.gov Identifier: | NCT01557803 History of Changes |
| Obsolete Identifiers: | NCT01549821 |
| Other Study ID Numbers: | MRU-HAS 006/2012 |
| Study First Received: | March 16, 2012 |
| Last Updated: | March 19, 2012 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
|
Immune reconstitution inflammatory syndrome Biomarkers HIV ART |
predictive factors epidemiological pattern Gabon |
Additional relevant MeSH terms:
|
Opportunistic Infections Immune Reconstitution Inflammatory Syndrome Infection |
Virus Diseases Parasitic Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on March 14, 2013
