Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome (IRIS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor:
Collaborators:
University Hospital Tuebingen
Albert Schweitzer Hospital
Information provided by (Responsible Party):
S. Janssen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01557803
First received: March 16, 2012
Last updated: March 19, 2012
Last verified: March 2012

March 16, 2012
March 19, 2012
January 2012
February 2014   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01557803 on ClinicalTrials.gov Archive Site
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Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome
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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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

Plasma, Paxgene RNA tubes and urine

Non-Probability Sample

Adult HIV patients starting anti retroviral therapy for the first time

  • Immune Reconstitution Inflammatory Syndrome
  • Opportunistic Infections
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Starting ART
Adult patients starting anti retroviral therapy for the first time
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
January 2016
February 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18 years
  • Informed consent
  • ART naive

Exclusion Criteria:

  • No informed consent
  • History of ART use
  • Pregnancy
Both
18 Years and older
No
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
 
NCT01557803
MRU-HAS 006/2012
No
S. Janssen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • University Hospital Tuebingen
  • Albert Schweitzer Hospital
Study Chair: MP Grobusch, MD, MSc, DTM&H Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP