Phase
Condition
Lung Disease
Hiv
Treatment
Delamanid
Bedaquiline
Clofazimine
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males and females age ≥12 years. Prior to study procedures, if ≥18 years of age,provides informed consent; if <18 years of age, child provides informed assent andhas a parent or guardian who provides informed consent on the participant's behalf.
Has pulmonary TB based on investigator assessment of all available information (e.g., chest radiograph, sputum smear, culture, molecular testing).
Has a sputum sample that is positive for M. tuberculosis that is rifamycin-resistantand fluoroquinolone-susceptible by molecular assay.
Is HIV seropositive or seronegative; HIV serostatus must be assessed at screening ifeither (a) HIV serostatus is unknown, or (b) the last documented negative HIV testwas more than two (2) months prior to screening.
Willing to attend scheduled follow-up visits and undergo study assessments.
Participants of child-bearing potential must agree either (a) to practice anadequate birth control (defined as one of the following oral contraceptives,intrauterine devices, contraceptive implants under the skin, contraceptive rings orpatches or injections, diaphragms with spermicide or condoms with foam) or (b) toabstain from heterosexual intercourse during study regimen.
Exclusion
Exclusion Criteria:
Current MTB isolate is known at screening to be fluoroquinolone-resistant.
History of allergy (hypersensitivity) or intolerability to one or more agents in theinvestigational regimens (i.e., Arms 1 and 2)
History of serotonin syndrome
History of symptomatic ventricular arrhythmia or is taking anti-arrhythmic agents
History of optic neuropathy or peripheral neuropathy
History of Ehlers-Danlos Syndrome, Marfan Syndrome or aortic aneurism
History of prior treatment with delamanid or linezolid for TB for greater than onemonth.
Has at screening received ≥14 days of second-line anti-TB drugs during current TBepisode
Has at screening a Karnofsky score of ≤40 or, in the opinion of the Investigator, isunlikely to survive 76 weeks.
Has at screening laboratory results that meet one or more of the following criteria:
Hemoglobin concentration 8.0 g/dL (<80 g/L)
Platelet count of <80,000/mm3
Absolute neutrophil count (ANC) <2000/ mm3
Serum creatinine >2.0 mg/dL (>177 µmol/L)
Serum ALT >3x upper limit of normal (ULN)
Total bilirubin >3x upper limit of normal (ULN)
Serum albumin <2.8 g/dL (<28 g/L)
For women of childbearing potential, a positive or indeterminate serumpregnancy test
For women of childbearing potential, has a positive or indeterminate urine pregnancytest on the day of randomization.
Has at screening a mean QTcF >450 msec based on three ECGs.
At screening requires ongoing use of prohibited drugs indicated in section 4.2
At screening, has weight less than 33 Kg
In the investigator's judgement is unable to provide consent (if ≥18 years of age)or unable to provide assent (if >12 years of age).
History of congestive heart failure
Study Design
Study Description
Connect with a study center
De La Salle Health Sciences Institute
Dasmariñas, 4114
PhilippinesActive - Recruiting
National Lung Hospital
Hanoi,
VietnamActive - Recruiting
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