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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01557803
First Posted: March 20, 2012
Last Update Posted: January 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University Hospital Tuebingen
Albert Schweitzer Hospital
Information provided by (Responsible Party):
S. Janssen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  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
Official Title: Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome in Lambaréné, Gabon

Further study details as provided by S. Janssen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • IRIS [ Time Frame: 12 months ]
    Development of immune reconstitution inflammatory syndrome


Secondary Outcome Measures:
  • Time to IRIS [ Time Frame: 12 months ]
    Time to development of immune reconstitution inflammatory syndrome


Biospecimen Retention:   Samples Without DNA
Plasma, Paxgene RNA tubes and urine

Enrollment: 107
Study Start Date: January 2012
Study Completion Date: January 2015
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult HIV patients starting anti retroviral therapy for the first time
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Informed consent
  • ART naive

Exclusion Criteria:

  • No informed consent
  • History of ART use
  • Pregnancy
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01557803


Locations
Gabon
Medical Research Unit - Albert Schweitzer Hospital
Lambaréné, Moyen Ogoué, Gabon, BP118
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
University Hospital Tuebingen
Albert Schweitzer Hospital
Investigators
Study Chair: MP Grobusch, MD, MSc Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

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
First Submitted: March 16, 2012
First Posted: March 20, 2012
Last Update Posted: January 14, 2015
Last Verified: January 2015

Keywords provided by S. Janssen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Immune reconstitution inflammatory syndrome
Biomarkers
HIV
ART
predictive factors
epidemiological pattern
Gabon

Additional relevant MeSH terms:
Syndrome
Opportunistic Infections
Immune Reconstitution Inflammatory Syndrome
Disease
Pathologic Processes
Infection
Virus Diseases
Parasitic Diseases
Immune System Diseases