Trial

DELIBERATE ACTG5343 Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and in Combination, Among Participants Taking Multidrug Treatment for Drug-Resistant Pulmonary Tuberculosis

Study Director
Kelly Dooley
Start Date
10 / 2015
Trial Phase
Phase II
Trial Status
enrolling
Current Enrollment
16
Target Enrollment
84
Overview

Bedaquiline (BDQ) and delamanid (DLM) are two newly approved anti-TB drugs and are both well tolerated. However, the combined effects of these two drugs have not been studied. Combining these two drugs, together with other anti-TB drugs, may improve outcomes for people with MDR-TB. The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of BDQ and DLM, alone and in combination, among participants (with or without HIV co-infection) taking multidrug treatment for MDR-TB. Researchers will specifically evaluate the effect of these drugs on the heart.

Participants will be randomly assigned to one of three arms: participants in Arm 1 will receive BDQ, participants in Arm 2 will receive DLM, and participants in Arm 3 will receive BDQ and DLM. All participants will receive their assigned study drugs for 24 weeks together with multidrug background treatment (MBT) for MDR-TB (not provided by the study). HIV-infected participants will also receive dolutegravir, to be used in combination with two NRTIs until study completion. NRTIs will not be provided by the study. Participants will be in the hospital for at least the first 2 months of the study, and they may remain in the hospital longer. Study visits will occur at entry, each week for 8 weeks after study entry, every other week until week 24, and 8 additional visits between weeks 25 and 128. Visits may include physical examinations, blood collection, urine collection, sputum sample collection, hair sample collection, chest x-rays, electrocardiograms (ECGs), and adherence questionnaires.

Study Chair: Kelly Dooley, MD, PhD Johns Hopkins Adult AIDS CRS
Study Chair: Gary Maartens, MBChB, MMed University of Cape Town