Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-28 @ 6:05 AM
Study NCT ID:
NCT01557803
Status:
COMPLETED
Last Update Posted:
2015-01-14
First Post:
2012-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054019', 'term': 'Immune Reconstitution Inflammatory Syndrome'}, {'id': 'D009894', 'term': 'Opportunistic Infections'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma, Paxgene RNA tubes and urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-13', 'studyFirstSubmitDate': '2012-03-16', 'studyFirstSubmitQcDate': '2012-03-19', 'lastUpdatePostDateStruct': {'date': '2015-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IRIS', 'timeFrame': '12 months', 'description': 'Development of immune reconstitution inflammatory syndrome'}], 'secondaryOutcomes': [{'measure': 'Time to IRIS', 'timeFrame': '12 months', 'description': 'Time to development of immune reconstitution inflammatory syndrome'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Immune reconstitution inflammatory syndrome', 'Biomarkers', 'HIV', 'ART', 'predictive factors', 'epidemiological pattern', 'Gabon'], 'conditions': ['Immune Reconstitution Inflammatory Syndrome', 'Opportunistic Infections']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult HIV patients starting anti retroviral therapy for the first time', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Informed consent\n* ART naive\n\nExclusion Criteria:\n\n* No informed consent\n* History of ART use\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01557803', 'acronym': 'IRIS', 'briefTitle': 'Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome', 'nctIdAliases': ['NCT01549821'], 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome in Lambaréné, Gabon', 'orgStudyIdInfo': {'id': 'MRU-HAS 006/2012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Starting ART', 'description': 'Adult patients starting anti retroviral therapy for the first time'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BP118', 'city': 'Lambaréné', 'state': 'Moyen Ogoué', 'country': 'Gabon', 'facility': 'Medical Research Unit - Albert Schweitzer Hospital', 'geoPoint': {'lat': -0.7001, 'lon': 10.24055}}], 'overallOfficials': [{'name': 'MP Grobusch, MD, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, {'name': 'Albert Schweitzer Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, MSc', 'investigatorFullName': 'S. Janssen', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}