MedTrace Logo

Preventing TB-IRIS in High-risk Patients: a Randomized Placebo-controlled Trial of Prednisone

NCT01924286 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2018-01-19

No results posted yet for this study

Summary

Tuberculosis (TB) is the most common opportunistic infection amongst HIV-infected patients starting antiretroviral therapy (ART) in developing countries and thus the most frequent form of immune reconstitution inflammatory syndrome (IRIS). Paradoxical TB-IRIS occurs in 8- 43% of patients starting ART while on TB treatment and results in morbidity, hospitalisation, consumes health care resources and TB-IRIS may be fatal. We have previously demonstrated in a clinical trial that prednisone reduces morbidity when used for treatment of paradoxical TB-IRIS. This trial is a double-blind placebo-controlled trial of prophylactic prednisone (40mg/day for 2 weeks followed by 20mg/day for 2 weeks, started on the same day as ART) in patients with TB who are identified as being at high risk for paradoxical TB-IRIS (starting ART within 30 days of initiating TB treatment and CD4 \< 100/μL). The trial will enroll 240 participants, randomised 1:1 (prednisone:placebo). The primary endpoint is development of paradoxical TB-IRIS, defined using international consensus case definitions. Secondary endpoints include time to IRIS event, severity of IRIS, quality of life assessment, mortality and corticosteroids adverse events. The trial is powered to determine a reduction in TB-IRIS events.

Conditions

Interventions

DRUG

Prednisone

DRUG

Placebo

Sponsors & Collaborators

  • Institute of Tropical Medicine, Belgium

    collaborator OTHER

  • Imperial College London

    collaborator OTHER

  • European and Developing Countries Clinical Trials Partnership (EDCTP)

    collaborator OTHER_GOV

  • Department of Science and Technology, South Africa

    collaborator UNKNOWN

  • University of Cape Town

    lead OTHER

Principal Investigators

  • Graeme Meintjes, MD MPH PhD · University of Cape Town

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-30
Primary Completion
2016-04-30
Completion
2017-04-30

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01924286 on ClinicalTrials.gov