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Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01557803
Acronym
IRIS
Enrollment
107
Registered
2012-03-20
Start date
2012-01-31
Completion date
2015-01-31
Last updated
2015-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune Reconstitution Inflammatory Syndrome, Opportunistic Infections

Keywords

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

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.

Interventions

None listed

Sponsors

University Hospital Tuebingen
CollaboratorOTHER
Albert Schweitzer Hospital
CollaboratorOTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* No informed consent * History of ART use * Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
IRIS12 monthsDevelopment of immune reconstitution inflammatory syndrome

Secondary

MeasureTime frameDescription
Time to IRIS12 monthsTime to development of immune reconstitution inflammatory syndrome

Countries

Gabon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026