TBTC Study 27/28 PK: Moxifloxacin Pharmacokinetics During TB Treatment
Status:
Completed
Trial end date:
2007-08-01
Target enrollment:
Participant gender:
Summary
This substudy of TBTC Studies 27 and 28 compares 1) the pharmacokinetics of moxifloxacin
alone versus moxifloxacin administered with rifampin in healthy volunteers and 2) the
pharmacokinetics of moxifloxacin among patients with tuberculosis being treated with
multidrug therapy (isoniazid or ethambutol, rifampin, and pyrazinamide) to those of healthy
volunteers receiving moxifloxacin plus rifampin. It also evaluates the association between
polymorphisms of MDR1 genotype (P-glycoprotein) and rifampin pharmacokinetic parameters, the
effect of polymorphisms of MDR1 genotype and/or rifampin pharmacokinetics on isoniazid
pharmacokinetic parameters adjusted for N-acetyltransferase genotype (NAT2), and determines
by multivariate regression analyses the associations between moxifloxacin or rifampin
pharmacokinetic parameters and markers of tuberculosis disease severity including the
covariates of two-month culture positivity, cavitary lung disease, Body Mass Index, weight,
duration of study treatment prior to PK, co-morbidities and C-reactive protein. Healthy
volunteers and TB patients receive frequent scheduled blood draws during a 24 hour period
after ingesting a dose of TB drugs.
Phase:
Phase 2
Details
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborators:
Bayer National Institutes of Health (NIH) US Department of Veterans Affairs VA Office of Research and Development
Treatments:
Fluoroquinolones Isoniazid Moxifloxacin Norgestimate, ethinyl estradiol drug combination