Overview

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

Status:
Completed

Trial end date:
2021-02-04

Target enrollment:

Participant gender:

Summary

This study evaluated 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).

Phase:

Phase 2

Details

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Treatments:

Bedaquiline
Diarylquinolines
Dolutegravir