Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome (IRIS)
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ClinicalTrials.gov Identifier: NCT01557803 |
Recruitment Status
:
Completed
First Posted
: March 20, 2012
Last Update Posted
: January 14, 2015
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Condition or disease |
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Immune Reconstitution Inflammatory Syndrome Opportunistic Infections |
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 : | January 2012 |
Actual Primary Completion Date : | February 2014 |
Actual Study Completion Date : | January 2015 |
Group/Cohort |
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Starting ART
Adult patients starting anti retroviral therapy for the first time
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- IRIS [ Time Frame: 12 months ]Development of immune reconstitution inflammatory syndrome
- Time to IRIS [ Time Frame: 12 months ]Time to development of immune reconstitution inflammatory syndrome
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Age > 18 years
- Informed consent
- ART naive
Exclusion Criteria:
- No informed consent
- History of ART use
- Pregnancy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01557803
Gabon | |
Medical Research Unit - Albert Schweitzer Hospital | |
Lambaréné, Moyen Ogoué, Gabon, BP118 |
Study Chair: | MP Grobusch, MD, MSc | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Responsible Party: | S. Janssen, MD, MSc, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
ClinicalTrials.gov Identifier: | NCT01557803 History of Changes |
Obsolete Identifiers: | NCT01549821 |
Other Study ID Numbers: |
MRU-HAS 006/2012 |
First Posted: | March 20, 2012 Key Record Dates |
Last Update Posted: | January 14, 2015 |
Last Verified: | January 2015 |
Keywords provided by S. Janssen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Immune reconstitution inflammatory syndrome Biomarkers HIV ART |
predictive factors epidemiological pattern Gabon |
Additional relevant MeSH terms:
Syndrome Opportunistic Infections Immune Reconstitution Inflammatory Syndrome Disease Pathologic Processes |
Infection Virus Diseases Parasitic Diseases Immune System Diseases |