Overview

This trial is active, not recruiting.

Condition multidrug resistant tuberculosis
Treatments delamanid, placebo, optimized background regimen (obr), antiretrovirals (arvs)
Phase phase 3
Sponsor Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date September 2011
End date May 2014
Trial size 511 participants
Trial identifier NCT01424670, 242-09-213

Summary

The purpose of this trial is to determine whether delamanid is effective in the treatment of Multidrug-resistant Tuberculosis (MDR TB) in combination with other MDR TB medications during 6 months of treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
Matching Placebo tablet
placebo
Matching Placebo
optimized background regimen (obr)
• Selection and administration of the treatment medications (i.e. OBRs) will be based on WHO's Guidelines for the programmatic management of drug-resistant TB, in conjunction with national TB program guidelines in each country
antiretrovirals (arvs)
• HIV treatment (i.e. ARVs) will be based on WHO guidelines and recommendations, and in compliance with local/national guidelines for HIV in South Africa (each site).
(Experimental)
100mg BID for 2 months and 200mg QD for 4 months
delamanid
100mg BID for 2 months and 200mg QD for 4 months
optimized background regimen (obr)
• Selection and administration of the treatment medications (i.e. OBRs) will be based on WHO's Guidelines for the programmatic management of drug-resistant TB, in conjunction with national TB program guidelines in each country
antiretrovirals (arvs)
• HIV treatment (i.e. ARVs) will be based on WHO guidelines and recommendations, and in compliance with local/national guidelines for HIV in South Africa (each site).

Primary Outcomes

Measure
Sputum Culture Conversion
time frame: 2 months
Time to Sputum Culture Conversion
time frame: 6 months

Secondary Outcomes

Measure
Sputum Culture Conversion
time frame: 2 months
Sputum Culture Conversion
time frame: 6 months
Durability of Sputum Culture Conversion
time frame: 18 months
Time to Sputum Culture Conversion
time frame: 6 months
Sputum Culture Conversion
time frame: 6 months
Durability of Sputum Culture Conversion
time frame: 30 months

Eligibility Criteria

Male or female participants from 18 years up to 69 years old.

Inclusion Criteria: - Provide written, informed consent - Current Diagnosis of MDR TB - Chest radiograph consistent with TB - Able to produce sputum - Negative urine pregnancy test and agree to use a highly effective method of birth control and/or adequate method of contraception Exclusion Criteria: - Allergy to any nitro-imidazoles or nitro-imidazole derivates - Diseases or conditions in which the use of nitro-imidazoles or nitro-imidazole derivates is contra-indicated - Use of disallowed medications - Renal impairment - Abnormal ECG - Cardiovascular disorders - BMI < 16 kg/m2 - Karnofsky score < 50% - Significant metabolic, gastrointestinal, neurological, psychiatric, or endocrine diseases, active malignancy - Alcohol abuse - Pregnant, breast-feeding, or planning to conceive or father a child - Recent use of methadone, benzodiazepines, cocaine, amphetamine/metamphetamine, tetrahydrocannabinol, barbiturates, and opiates - Previous exposure to delamanid - Administered an IMP within 1 month prior to Visit 1 - Evidence of XDR TB based on the definition from WHO - HIV co-infection for patients screened at sites not participating in the HIV subtrial

Additional Information

Official title A Phase 3, Multicenter,Randomized, Double-blind, Placebo-controlled, Parallel Group Trial to Evaluate the Safety and Efficacy of Delamanid Administered Orally as 200 mg Total Daily Dose for Six Months in Patients With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis
Description The purpose of this trial is to evaluate the efficacy of delamanid administered orally as 100 mg twice daily (BID) for 2 months followed by 200 mg once daily (QD) for 4 months in combination with an optimized background regimen (OBR) versus placebo with OBR during the 6-month intensive phase of MDR TB treatment. This trial is a multicenter, randomized, double-blind, stratified, placebo-controlled trial conducted globally in 2 parallel groups at approximately 15 sites qualified to treat MDR TB. In addition, a subtrial comprised of human immunodeficiency virus (HIV) positive patients who will be on antiretrovirals (ARVs) during the trial and will be randomized to OBR plus placebo or OBR plus delamanid will be conducted at a limited number of these sites that have been prequalified as having an integrated approach to TB and HIV treatment and management and a sufficient population of MDR TB patients co-infected with HIV for enrollment.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Otsuka Pharmaceutical Development & Commercialization, Inc..