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Trial record 39 of 507 for:    MOXIFLOXACIN

TBTC Study 27/28 PK: Moxifloxacin Pharmacokinetics During TB Treatment

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ClinicalTrials.gov Identifier: NCT00164463
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : June 8, 2011
Sponsor:
Collaborators:
US Department of Veterans Affairs
Bayer
National Institutes of Health (NIH)
Information provided by:
Centers for Disease Control and Prevention

Brief 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.

Condition or disease Intervention/treatment Phase
Tuberculosis Drug: Moxifloxacin Drug: Isoniazid Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: TBTC Study 27/28 PK: Pharmacokinetic Issues in the Use of Moxifloxacin for Treatment of Tuberculosis
Study Start Date : July 2004
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
Experimental: Moxifloxacin
Moxifloxacin 400 mg po qd given 5 of 7 days per week
Drug: Moxifloxacin
400 mg po qd 5/7 days per week

Active Comparator: Isoniazid
Isoniazid 300 mg po qd given 5/7 days per week
Drug: Isoniazid
isoniazid 300 mg po qd 5/7 days per week




Primary Outcome Measures :
  1. Compare in healthy volunteers the pharmacokinetics of moxifloxacin alone versus moxifloxacin administered with rifampin. [ Time Frame: study period ]
  2. Compare 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. [ Time Frame: study period ]

Secondary Outcome Measures :
  1. Determine variation of moxifloxacin pharmacokinetics (PK) among patients with pulmonary TB during treatment. [ Time Frame: study period ]
  2. Compare serum concentrations of isoniazid rifampin and pyrazinamide among patients being treated with moxifloxacin versus patients being treated with ethambutol as the fourth drug in multidrug treatment. [ Time Frame: study period ]
  3. Compare serum concentrations of rifampin, pyrazinamide and ethambutol among patients being treated with moxifloxacin versus patients being treated with isoniazid as the fourth drug [ Time Frame: study period ]
  4. Determine the association between polymorphisms of MDR1 genotype (P-glycoprotein) and rifampin PK parameters. [ Time Frame: study period ]
  5. Determine the effect of polymorphisms of MDR1 genotype and/or rifampin PK on isoniazid PK parameters adjusted for N-acetyltransferase genotype (NAT2). [ Time Frame: study period ]
  6. Determine the effects of polymorphisms of MDR1 and UGT genotypes on moxifloxacin PK parameters. [ Time Frame: study period ]
  7. Determine by multivariate regression analyses the associations between moxifloxacin or rifampin PK parameters and markers of disease severity. [ Time Frame: study period ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For Healthy Volunteers:

  • Provision of informed consent for the study.
  • Age > 18 years.
  • Willingness to be available for 2 weeks of DOT.
  • Willingness to be admitted to a GCRC or hospital on two occasions.
  • Women of child-bearing potential must agree to practice an adequate method of birth control. Barrier methods of contraception or abstinence from sexual activity are satisfactory methods.
  • Willingness to have HIV testing done if documented results are not available. (A prior negative result must be obtained within one year and consists of a negative HIV ELISA. A positive result must be both a positive HIV ELISA and Western Blot, or a plasma HIV PCR RNA level greater than 5000 copies/ml).
  • Laboratory screening (if not already available) within 30 days of the first PK admission:

    • Serum potassium within normal limits
    • Hematocrit > 35%
    • Absolute neutrophil count > 1000 /mm3
    • AST < 3 times the upper limit of normal
    • Bilirubin < 2 times the upper limit of normal
    • Creatinine < 2 times the upper limit of normal
  • Eligible and enrolled for medical health care sponsored by the United States federal government (such as the Veterans Administration enrollment Priority 1 through 7, VHA Directive 2003-003).

For Patients with Tuberculosis Enrolled in TBTC Study 27 or Study 28:

  • Any patient enrolled in TBTC Study 27 or Study 28 receiving a daily (5-7 days per week) regimen.
  • Provision of informed consent for the study.
  • Willingness to be admitted to a GCRC or hospital on one occasion.

Exclusion Criteria:

For Healthy Volunteers:

  • Karnofsky score less than 90
  • Pregnancy or breast-feeding. (A negative pregnancy test is required for women of childbearing potential within 14 days before the first dose of moxifloxacin.)
  • Known allergy to any fluoroquinolone or rifamycin antibiotic
  • Current or planned therapy during the study with drugs having unacceptable interactions with rifampin
  • History of prolonged QT syndrome or current or planned therapy with quinidine, procainamide, amiodarone, sotalol, or ziprasidone during period of administration of moxifloxacin and for one week after treatment

For Patients with Tuberculosis Enrolled in TBTC Study 27 or Study 28:

  • Severe anemia as defined by a hematocrit less than 25% (most recent value, measured within 30 days of the PK study).
  • History of severe liver disease classified as Child Pugh Class C.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00164463


Locations
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United States, California
University of Southern California Medical Center
Los Angeles, California, United States, 90033
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21231
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Texas
University of North Texas Health Science Center
Fort Worth, Texas, United States, 76104
Houston Veterans Administration Medical Center
Houston, Texas, United States, 77030
Audie L Murphy Memorial Veterans Administration Medical Center
San Antonio, Texas, United States, 78284
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V5Z 1L8
Uganda
Makerere University Medical School
Kampala, Uganda
Sponsors and Collaborators
Centers for Disease Control and Prevention
US Department of Veterans Affairs
Bayer
National Institutes of Health (NIH)
Investigators
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Study Chair: Marc Weiner, MD VAMC and University of Texas Health Science Center San Antonio
Study Chair: William Burman, MD Denver Public Health

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: William R. Mac Kenzie, MD / project officer, Tuberculosis Trial Consortium
ClinicalTrials.gov Identifier: NCT00164463     History of Changes
Other Study ID Numbers: CDC-NCHSTP-4222
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: June 2011
Keywords provided by Centers for Disease Control and Prevention:
tuberculosis
TB
Additional relevant MeSH terms:
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Moxifloxacin
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Isoniazid
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antitubercular Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents