Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome

NCT01557803 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 107

Last updated 2015-01-14

No results posted yet for this study

Summary

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.

Conditions

  • Immune Reconstitution Inflammatory Syndrome
  • Opportunistic Infections

Sponsors & Collaborators

  • University Hospital Tuebingen

    collaborator OTHER
  • Albert Schweitzer Hospital

    collaborator OTHER
  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • MP Grobusch, MD, MSc · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-02-28
Completion
2015-01-31

Countries

  • Gabon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01557803 on ClinicalTrials.gov