Last updated on August 2018

Evaluating the Safety Tolerability and Pharmacokinetics of Bedaquiline and Delamanid Alone and in Combination For Drug-Resistant Pulmonary Tuberculosis

Brief description of study

This study will evaluate the safety, tolerability, and pharmacokinetics of the anti-tuberculosis (TB) drugs bedaquiline (BDQ) and delamanid (DLM), alone and in combination, among participants (with or without HIV co-infection) taking multidrug treatment for multidrug-resistant tuberculosis (MDR-TB) or rifampin-monoresistant TB (RR-TB).

Detailed Study Description

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 or RR-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 or RR-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 or RR-TB (not provided by the study). HIV-infected participants will also receive dolutegravir, to be used in combination with two nucleoside reverse transcriptase inhibitors (NRTIs) until study completion. NRTIs will not be provided by the study. All participants are expected to be hospitalized for 2 weeks starting at study entry. Participants may also be hospitalized for longer than 2 weeks.

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, pregnancy testing, electrocardiograms (ECGs), and adherence questionnaires.

Participants may also be asked to take part in an optional cerebrospinal fluid sampling study that will entail a lumbar puncture, to be done at weeks 8 or 24.

Clinical Study Identifier: NCT02583048

Contact Investigators or Research Sites near you

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Chris Hikuam

South African Tuberculosis Vaccine Initiative (SATVI) CRS
Cape Town, South Africa

Christelle v. Niekerk

Task Applied Science (TASK) CRS
Cape Town, South Africa