BEDAQUILINE AND DELAMANID FOR MDR-TB TREATMENT
- Conditions
- -A15 Respiratory tuberculosis, bacteriologically and histologically confirmedRespiratory tuberculosis, bacteriologically and histologically confirmedA15
- Registration Number
- PER-016-16
- Lead Sponsor
- Institutos Nacionales de Salud (NIH, siglas en ingles) de los Estados Unidos de America,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 6
•Men and women age 18 years of age.
•Documented pulmonary infection due to strains of M. tuberculosis with resistance to isoniazid (INH) and rifampin (RIF) from a sputum sample collected within 60 days prior to entry.
•Laboratory confirmation of infection with a Mycobacterium tuberculosis strain that is susceptible to fluoroquinolones and aminoglycosides within 60 days prior to entry.
•HIV infection status must be documented as either absent or present
•For HIV-positive candidates only: CD4+ count greater than or equal to 100 cells/mm3 within 60 days prior to entry.
•For females of reproductive potential, negative serum pregnancy test within 48 hours prior to entry.
•Female and male participants of reproductive potential who are participating in sexual activity that could lead to pregnancy must agree to use one of the following forms of birth control while receiving TB study medications and for 6 months after stopping TB study medications:
•Chest x-ray performed within 60 days prior to entry to classify participant as having cavitary or non-cavitary disease.
•Documentation of Karnofsky performance score 50 within 14 days prior to study entry.
•Ability and willingness of participant or legally authorized representative to provide informed consent.
•Willingness to be hospitalized for at least 2 months.
•Taking MBT for a minimum of 7 days within the 10 days prior to entry
•History of clinically relevant, currently active or underlying gastrointestinal, hepatic, cardiovascular, nervous system, psychiatric, metabolic (eg, untreated hypothyroidism), renal, respiratory (other than due to TB), inflammatory, neoplastic, skin, immunological or infectious disease, which is not stable and controlled, that in the opinion of the investigator would preclude safe participation in the trial.
•Clinically relevant extrapulmonary TB, in the opinion of the site investigator, including but not limited to CNS TB or TB osteoarthritis.
•Previous treatment for MDR-TB, other than for the qualifying episode, at any time in the past.
•Receipt of BDQ or DLM at any time in the past.
•Breast-feeding.
•QTcF interval > 450 ms within 72 hours prior to entry.
•Clinically significant ECG abnormality in the opinion of the site investigator within 60 days prior to entry, including but not limited to second or third degree atrioventricular (AV) block, prolongation of the QRS complex over 120 ms (in both male and female participants), or clinically important arrhythmia.
• Current clinically relevant cardiovascular disorder in the opinion of the site investigator, including but not limited to heart failure, coronary heart disease, arrhythmia, or tachyarrhythmia.
•Known family history of Long QT Syndrome in a first-degree relative (ie, parent, offspring, or sibling).
•Requirement or expected requirement for protease inhibitors (PIs), EFV, or any other medication that is a moderate to strong inhibitor or inducer of CYP3A and CYP3A4 over the 24 weeks of study treatment.
•Requirement or expected requirement for a medication that significantly prolongs QTc, including but not limited to clofazimine and moxifloxacin (levofloxacin is acceptable), from 48 hours prior to study entry through 4 weeks after discontinuation of study treatment (week 28).
•Known allergy/sensitivity or any hypersensitivity to components of study TB drugs or their formulation or to the nitroimidazole class of antibiotics.
•Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
•Any of the following laboratory abnormalities within 14 days prior to entry at any network-approved non-US laboratory that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate external quality assurance programs.
a.Serum creatinine >1.4 x ULN
b.Lipase >1.6 x ULN
c.ALT >2.5 x ULN
d.Total bilirubin >1.6 x ULN
e.Potassium <3.4 or >5.6 mmol/L; magnesium <0.59 mmol/L; calcium <1.75 mmol/L
•Known current hepatitis B or C infection, current treatment for hepatitis B or hepatitis C infection, or positive for hepatitis B surface antigen or hepatitis C antibodies within 60 days prior to entry.
•Among participants with HIV infection, in whom use of DTG is anticipated, any of the following:
a.Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, esophageal varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones)
b.History or presence of allergy to DTG or its components
c.Severe hepatic impairment (Class C) as determined by Child-Pugh classification
d.Previous use of raltegravir
•Documentation of any new and/or unstable AIDS-defining ill
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method