A Multi-Site Double-Blind Placebo Controlled Randomised Clinical Trial
to Prevent Immune Reconstitution Inflammatory Syndrome with Non-
Steroid Anti-Inflammatory Drugs
EDCTP Project
TA.2008.40200.021
EDCTP Program
EDCTP1
EDCTP Project Call
Senior Fellowship (SF)
Project Objectives
Evaluate the impact of NSAIDs compared to placebo on preventing
TB-IRIS in a TB-HIV infected South African Adults
Evaluate the impact of NSAIDs compared to placebo on CD4+ T-cell
count recovery following initiation of ART in TB-HIV infected South
African Adults
Evaluate the impact of NSAIDs compared to placebo on HIV-1 RNA
response following initiation of ART in TB-HIV infected South African
Adults
Evaluate the impact of NSAIDs compared to placebo on adherence of
both TB and HIV medication following initiation of ART in TB-HIV
infected South African Adults
Assess the impact of NSAIDs compared to placebo on quality of life
Study Design
Phase II: Randomised placebo control trial for prevention of TB-IRIS with
non-steroidal ant-inflammatory drugs on TB patients on HAART
Host Organisation
Department
Institution
Country
Stellenbosch University (SU)
South Africa
Results & Outcomes
Enrolment into the study started on 1 April 2014 .
A GMP manufacturing facility for preparation of the double-blind
(double-dummy capsules) formulation of Meloxicam (Mobic®) and
placebo has been finalized; this work has been managed by the
University of the Western Cape (Dr R Bapoo) under supervision of the
Division of Pharmacology, Stellenbosch University (Professor Rosenkranz,
co-investigator on this project and head of Division of Clinical
Pharmacology at Stellenbosch University).
Current Organisation
Current Job Title
Biography
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