EDCTP Alumni Network

Call	Senior Fellowship (SF)
Programme	EDCTP1
Start Date	2010-02-09
End Date	2014-12-31
Project Code	TA.2008.40200.021
Status	Completed

Title

A Multi-Site Double-Blind Placebo Controlled Randomised Clinical Trial to Prevent Immune Reconstitution Inflammatory Syndrome with Non- Steroid Anti-Inflammatory Drugs

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

Host Organisation

Participants

Study Design

Phase II: Randomised placebo control trial for prevention of TB-IRIS with non-steroidal ant-inflammatory drugs on TB patients on HAART

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).