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

This study has been completed.
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: January 13, 2015
Last verified: January 2015
History of Changes
  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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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

Primary Outcome Measures:
  • IRIS [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Development of immune reconstitution inflammatory syndrome


Secondary Outcome Measures:
  • Time to IRIS [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: January 13, 2015
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:
Immune Reconstitution Inflammatory Syndrome
Opportunistic Infections
Syndrome
Disease
Immune System Diseases
 Infection
Parasitic Diseases
Pathologic Processes
Virus Diseases

ClinicalTrials.gov processed this record on February 27, 2015