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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

Institution Country
Stellenbosch University (SU) South Africa

Participants

Name Institution Country
Robert Colebunders University of Antwerp Belgium
Ingrid Wilson Stellenbosch University (SU) South Africa
Gary Simon George Washington University United States

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).

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