IRIS: Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)
• Overall Status: Completed
• CT.gov ID: NCT01557803
• Collaborator: University Hospital Tuebingen (Other), Albert Schweitzer Hospital (Other)
• Enrollment: 107
• Location: 1
• Duration (Months): 36
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Immune Reconstitution Inflammatory Syndrome; Opportunistic Infections

Study Design

• Study Type: Observational
• Actual Enrollment: 107 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome in Lambaréné, Gabon
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Feb 1, 2014
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Starting ART Adult patients starting anti retroviral therapy for the first time

Outcome Measures

Primary Outcome Measures

1. IRIS [12 months]

   Development of immune reconstitution inflammatory syndrome

Secondary Outcome Measures

1. Time to IRIS [12 months]

   Time to development of immune reconstitution inflammatory syndrome

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age > 18 years

• Informed consent

• ART naive

Exclusion Criteria:

• No informed consent

• History of ART use

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: S. Janssen, MD, MSc, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• ClinicalTrials.gov Identifier: NCT01557803
• Other Study ID Numbers: MRU-HAS 006/2012; NCT01549821
• First Posted: Mar 20, 2012
• Last Update Posted: Jan 14, 2015
• Last Verified: Jan 1, 2015

• Keywords provided by S. Janssen, MD, MSc, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): Immune reconstitution inflammatory syndrome; Biomarkers; HIV; ART; predictive factors; epidemiological pattern; Gabon
• Additional relevant MeSH terms: Opportunistic Infections; Immune Reconstitution Inflammatory Syndrome; Syndrome

Study Results

No Results Posted as of Jan 14, 2015