Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON20147

Enrollment

200

Registered

2012-03-02

Start date

2012-02-27

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Immune Reconstitution Inflammatory Syndrome, HIV, antiretroviral therapy (ART)

Interventions

Enrolment: 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 immunolo

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. No informed consent; 2. History of ART; 3. Pregnancy.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. Obtain insoght in the epidemiological characteristics of IRIS in Gabon; 2. Describe HIV related ophtalmological problems in this setting.	—

Contacts

Public ContactS. Janssen

PO Box 22660

S.Janssen@amc.uva.nl+31 (0)20 5664380

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)