Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome

Opportunistic Infections Clinical Trial

— IRIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01557803
• Other study ID #: MRU-HAS 006/2012
• Status: Completed
• Phase: N/A
• First received: March 16, 2012
• Last updated: January 13, 2015
• Start date: January 2012
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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.

Other known NCT identifiers

• NCT01549821

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: January 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• Informed consent

• ART naive

Exclusion Criteria:

• No informed consent

• History of ART use

• Pregnancy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Immune Reconstitution Inflammatory Syndrome
• Opportunistic Infections
• Syndrome

Locations

Country	Name	City	State
Gabon	Medical Research Unit - Albert Schweitzer Hospital	Lambaréné	Moyen Ogoué

Sponsors (3)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Albert Schweitzer Hospital, University Hospital Tuebingen

Country where clinical trial is conducted

Gabon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IRIS	Development of immune reconstitution inflammatory syndrome	12 months	No
Secondary	Time to IRIS	Time to development of immune reconstitution inflammatory syndrome	12 months	No