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

PHASE2CompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

August 15, 2016

Primary Completion Date

January 7, 2019

Study Completion Date

February 4, 2021

Conditions
TuberculosisHIV Infections
Interventions
DRUG

Bedaquiline

Four 100 mg tablets (400 mg) orally once a day for 2 weeks, followed by two 100 mg tablets (200 mg) orally three times a week for 22 weeks.

DRUG

Delamanid

Two 50 mg tablets (100 mg) orally with food twice a day for 24 weeks.

DRUG

Dolutegravir

For HIV-positive participants only: one 50 mg tablet orally once daily, to be used in combination with two NRTIs until study completion. (NRTIs were not provided by the study.)

DRUG

Multidrug Background Treatment (MBT) for TB

A standardized MBT regimen for MDR- or RR-TB except in cases where a participant had known resistance to one of the components of local standard treatment. MBT was provided by the local program.

Trial Locations (3)

7530

Task Applied Science (TASK) CRS, Cape Town

7705

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

15063

Barranco CRS, Lima

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT02583048 - Evaluating the Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and in Combination, For Drug-Resistant Pulmonary Tuberculosis | Biotech Hunter | Biotech Hunter