The international PravaTB consortium has recently received a prestigious 4.9 million Euro award from the European & Developing Countries Clinical Trials Partnership (EDCTP) to conduct a clinical trial investigating the use of statins to prevent chronic lung inflammation and potentially TB relapse. Patients with recurrent TB suffer persistent morbidity caused by post-TB destructive lung disease. Statins have broad-range immune-modulatory and anti-inflammatory properties which may be beneficial in the treatment of TB by reducing lung pathology, accelerating Mycobacterium tuberculosis clearance, and improving lung functions.
This proof-of-concept phase IIB, double-blind, randomized, placebo-controlled trial aims to evaluate the safety and efficacy of statins to reduce inflammation after TB treatment completion in HIV-infected and HIV-uninfected adults measured by FDG-PET/CT. Secondary objectives include immunological biomarkers and transcriptional profiling to identify correlates of treatment outcome.
The consortium is coordinated by Reto Guler at the University of Cape Town, South Africa with partners Friedrich Thienemann (chief principal investigator; University of Zürich), and Sandra Mukasa (local PI; University of Cape Town). Other project partners include Robert J. Wilkinson (Imperial College London), Claudia Schacht (LINQ Management GmbH, Germany), Gunar Günther and Emmanuel Nepolo (University of Namibia).
The University of Namibia (UNAM) hosted the PravaTB kickoff meeting from 16 to 18 January 2019. The kickoff meeting commenced with a visit to Katutura Hospital’s TB ward in Windhoek followed by a tour of the UNAM medical campus and laboratories.
In addition to the clinical trial, capacity building for the University of Namibia is an important pillar of the PravaTB project, with activities planned to train clinical, laboratory and administrative staff.
PravaTB will receive €4,945,770 in funding from the second programme of the European & Developing Countries Clinical Trials Partnership (EDCTP2) over the trial duration of four years, starting from January 1st 2019.
Text supplied by Julia Büch, LINQ management GmbH, and Reto Guler. Photographs supplied by Julia Büch.