CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 84 enrolled
Drug / intervention
Bedaquiline +3 moredrug
Likely dose
Bedaquiline 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02583048
NCT02583048Phase 2Completed
CompareCT.gov

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

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Oct 21, 2015·Updated Jan 27, 2022

In Brief

A Phase 2 clinical trial evaluating Bedaquiline, Delamanid, and 2 other interventions for Tuberculosis and HIV Infections. Completed, enrolled 84 participants across 3 sites in 2 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis, HIV Infections
CountriesPeru, South Africa
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 21, 2015
Enrollment StartAug 15, 2016
Primary CompletionJan 7, 2019
Study CompletionFeb 4, 2021
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 10.7 years ago

Interventions

Bedaquilinedrug

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.

Delamaniddrug

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

Dolutegravirdrug

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.)

Multidrug Background Treatment (MBT) for TBdrug

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.