A. On-going trials
1. The Evaluation of a Standardized Treatment Regimen of Anti-Tuberculosis Drugs for Patients with MDR-TB (STREAM), Multicenter Trial (Ethiopia, South Africa, Mongolia & Vietnam).
PI: TesfamariamMebrhatu (MD, MPH) - AHRI/ALERT and Dr Daniel Meressa (MD, PGSDip); Sponsor: The International Union Against Tuberculosis and Lung Disease (IUATLD) in collaboration with MRC-CTU-UK
Generally, anti-TB therapy including MDR TB is based on experts’ opinion with median treatment success rate of ~60% (WHO 2009). A so-called ‘Bangladesh regimen’, a nine months regimen, achieved relapse free cure rate of 87.9% among MDR-TB patients (Van Deunet al., AJRCCM 2010). STREAM is therefore testing whether this success can be duplicated in a larger controlled trial. STREAM is a multi-country trial involvingseveral clinical sites. ALERT hospital and St Peter’s TB Specialized Hospitalare the two clinical sites in Ethiopia.
2. Bioequivalence (BE) Clinical Studies, New Development. PI: MekonnenTeferi (DVM, MSc.) Bioequivalence clinical center at AHRI was established in September 2013 as clinical affiliate to the Regional Bioequivalence Center (RBEC) following the establishment of the latter in 2012. The center aims at having a locally accessible, GCP/GLP compliant and WHO qualified BE testing center in East Africa.
Two BE pilot studies have been conducted for the bioavailability of generic products of local manufacturers in comparison with the respective brand products..Both of the pilot studies have been successfully completed with acceptable standards.Currently, study documents are compiled for possible WHO review, inspection and qualification formeeting international standardsduring study conduct as well as facilities at the clinical site and the analytical lab at RBEC. The clinical center at AHRI has a phase I clinical site standard facilities including study screening and admission wards.
B. Other activities: study protocol development, quality assurance and GCP training
There are few more trials under site preparation for kick-off and others through protocol development. In parallel, the clinical trial team is striving to improve the quality of study conduct and meeting international standards through establishing a dedicated QA unit and accredited clinical laboratory at AHRI. The team at AHRI is also engaged in preparing and providing GCP training to its staff and local collaborators.