|- candidate number||11268|
|- NTR Number||NTR3329|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-mrt-2012|
|- Secondary IDs||06_2012_IRIS Medical Research Unit - Albert Schweitzer Hospital, Lambaréné, Gabon|
|- Public Title||Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome.|
|- Scientific Title||Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome.|
|- hypothesis||The purpose of this study is:|
1. To identify clinical and biological predictors for the development of IRIS in HIV infected patients and;
2. To obtain insight into the pathogenesis of this syndrome;
3. To describe the epidemiological pattern of IRIS in Gabon.
|- Healt Condition(s) or Problem(s) studied||Immune Reconstitution Inflammatory Syndrome, HIV-positive patients, Antiretroviral therapy (ART)|
|- Inclusion criteria||1. Age > 18 years;|
2. Informed consent;
3. Male and female patients;
4. HIV positive;
5. Eligible for ART;
6. ART naïve, or history of single dose nevirapine during previous pregnancy.
|- Exclusion criteria||1. No informed consent;|
2. History of ART;
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||27-feb-2012|
|- planned closingdate||27-feb-2016|
|- Target number of participants||200|
Extensive history & physical exam, routine chest X ray & abdominal ultrasound (signs of TB), routine haematology & chemistry & serology (hep B & TPHA), storage of plasma for later immunological assays, visual acuity, fundoscopy.
Extensive history & physical exam, abdominal ultrasound (monthly), routine haematology & chemistry, storage of plasma for later immunological assays, visual acuity, fundoscopy in case of detoriated visual acuity.
|- Primary outcome||After finalizing this observational study a nested case-control study will be performed within this cohort, in order to:|
1. Identify predicors and early diagnostic factors for the different types of IRIS, with focus on TB IRIS, cryptococcal IRIS and CMV IRIS;
2. Obtain more insight in the pathogenesis of the different types of IRIS.
|- Secondary outcome||1. Obtain insoght in the epidemiological characteristics of IRIS in Gabon;|
2. Describe HIV related ophtalmological problems in this setting.
|- Timepoints||Scheduled follow up visits:|
1. 2 weekly the first 2 months;
2. Month 3-12 monthly.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD. S. Janssen|
|- CONTACT for SCIENTIFIC QUERIES||MD. S. Janssen|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|UBS Optimus Foundation, University of Tuebingen, Medical Research Unit , Albert Schweitzer Hospital, Lambaréné, Gabon|
|- Brief summary||Background: |
Immune Reconstitution Inflammatory Syndrome (IRIS) is a term used to describe the paradoxical worsening of a pre-existing infection or the presentation of a previously undiagnosed condition in HIV infected patients soon after the commencement of antiretroviral therapy (ART).
Rationale: Prediction and diagnosis of IRIS remains complex and pathogenesis is incompletely understood.
Study design & setting:
Prospective, observational cohort with nested case-control design; 200 HIV infected patients starting ART will be followed in and around Lambaréné, Gabon.
Patients will be followed up monthly; clinical and laboratory data will be collected and plasma will be stored for later analysis. Putative biomarkers will be assessed for their predictive value and insight will be obtained in which inflammatory pathways become activated during the different appearances of IRIS.
|- Main changes (audit trail)|
|- RECORD||2-mrt-2012 - 16-mrt-2012|