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

> **NCT02583048** · PHASE2 · COMPLETED · sponsor: **National Institute of Allergy and Infectious Diseases (NIAID)** · enrollment: 84 (actual)

## Conditions studied

- Tuberculosis
- HIV Infections

## Interventions

- **DRUG:** Bedaquiline
- **DRUG:** Delamanid
- **DRUG:** Dolutegravir
- **DRUG:** Multidrug Background Treatment (MBT) for TB

## Key facts

- **NCT ID:** NCT02583048
- **Lead sponsor:** National Institute of Allergy and Infectious Diseases (NIAID)
- **Sponsor class:** NIH
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2016-08-15
- **Primary completion:** 2019-01-07
- **Final completion:** 2021-02-04
- **Target enrollment:** 84 (ACTUAL)
- **Last updated:** 2022-01-27


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02583048

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02583048, "Evaluating the Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and in Combination, For Drug-Resistant Pulmonary Tuberculosis". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT02583048. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
