Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome

NCT ID: NCT01557803

Last Updated: 2015-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

107 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Immune Reconstitution Inflammatory Syndrome Opportunistic Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Starting ART

Adult patients starting anti retroviral therapy for the first time

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* No informed consent
* History of ART use
* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role collaborator

Albert Schweitzer Hospital

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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S. Janssen

MD, MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MP Grobusch, MD, MSc

Role: STUDY_CHAIR

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

Locations

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Medical Research Unit - Albert Schweitzer Hospital

Lambaréné, Moyen Ogoué, Gabon

Site Status

Countries

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Gabon

Other Identifiers

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MRU-HAS 006/2012

Identifier Type: -

Identifier Source: org_study_id

NCT01549821

Identifier Type: -

Identifier Source: nct_alias

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