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

January 13, 2015 updated by: S. Janssen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome in Lambaréné, Gabon

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

107

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Gabon
    • Moyen Ogoué
      • Lambaréné, Moyen Ogoué, Gabon, BP118
        • Medical Research Unit - Albert Schweitzer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult HIV patients starting anti retroviral therapy for the first time

Description

Inclusion Criteria:

  • Age > 18 years
  • Informed consent
  • ART naive

Exclusion Criteria:

  • No informed consent
  • History of ART use
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Starting ART
Adult patients starting anti retroviral therapy for the first time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IRIS
Time Frame: 12 months
Development of immune reconstitution inflammatory syndrome
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to IRIS
Time Frame: 12 months
Time to development of immune reconstitution inflammatory syndrome
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborators

University Hospital Tuebingen
Albert Schweitzer Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

February 1, 2014

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

March 16, 2012

First Submitted That Met QC Criteria

March 19, 2012

First Posted (ESTIMATE)

March 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 14, 2015

Last Update Submitted That Met QC Criteria

January 13, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRU-HAS 006/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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