Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome

NCT01557803 | Completed

• 1 other identifier: MRU-HAS 006/2012
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Reconstitution Inflammatory Syndrome; Opportunistic Infections

Keywords

Immune reconstitution inflammatory syndrome; Biomarkers; HIV; ART; predictive factors; epidemiological pattern; Gabon

Outcome Measures

Primary Outcomes (1)

• IRIS

  Development of immune reconstitution inflammatory syndrome

  12 months

Secondary Outcomes (1)

• Time to IRIS

  12 months

Study Arms (1)

Starting ART

Adult patients starting anti retroviral therapy for the first time

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult HIV patients starting anti retroviral therapy for the first time

You may qualify if:

• Age \> 18 years
• Informed consent
• ART naive

You may not qualify if:

• No informed consent
• History of ART use
• Pregnancy

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• University Hospital Tuebingen: collaborator
• Albert Schweitzer Hospital: collaborator

Study Sites (1)

Medical Research Unit - Albert Schweitzer Hospital

Lambaréné, Moyen Ogoué, BP118, Gabon

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, Paxgene RNA tubes and urine

MeSH Terms

Conditions

Immune Reconstitution Inflammatory Syndrome; Opportunistic Infections

Condition Hierarchy (Ancestors)

Immune System Diseases; Infections

Study Officials

• MP Grobusch, MD, MSc

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: March 20, 2012
• Study Start: January 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: January 1, 2015
• Last Updated: January 14, 2015

Record last verified: 2015-01

Locations

GA (1)