A Phase 3, Multicenter,Randomized, Double-blind, Placebo-controlled, Parallel Group Trial to Evaluate the Safety and Efficacy of Delamanid Administered Orally as 200 mg Total Daily Dose for Six Months in Patients With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis. 242-09-213

Study Director
Rajesh Gupta, MD
Start Date
9 / 2011
Trial Phase
Phase III
Trial Status
in data analysis
Current Enrollment
Target Enrollment


The purpose of this trial is to evaluate the efficacy of delamanid administered orally as 100 mg twice daily (BID) for 2 months followed by 200 mg once daily (QD) for 4 months in combination with an optimized background regimen (OBR) versus placebo with OBR during the 6-month intensive phase of MDR TB treatment. This trial is a multicenter, randomized, double-blind, stratified, placebo-controlled trial conducted globally in 2 parallel groups at approximately 18 sites in 7 countries qualified to treat MDR TB. In addition, a subtrial comprised of human immunodeficiency virus (HIV) positive patients who will be on antiretrovirals (ARVs) during the trial and will be randomized to OBR plus placebo or OBR plus delamanid will be conducted sites in South Africa that have been prequalified as having an integrated approach to TB and HIV treatment and management and a sufficient population of MDR TB patients co-infected with HIV for enrollment.

Experimental: Delamanid

100mg BID for 2 months and 200mg QD for 4 months

Drug: Delamanid

100mg BID for 2 months and 200mg QD for 4 months

Drug: Optimized Background Regimen (OBR)

• Selection and administration of the treatment medications (i.e. OBRs) will be based on WHO's Guidelines for the programmatic management of drug-resistant TB, in conjunction with national TB program guidelines in each country. ARVs will be administered as standard-of-care.

Drug: Antiretrovirals (ARVs)

• HIV treatment (i.e. ARVs) will be based on WHO guidelines and recommendations, and in compliance with local/national guidelines for HIV in South Africa (each site). ARVs will be administered as standard-of-care.