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TuberculosisPhase 2NCT00164463

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

A Phase 2 study testing Moxifloxacin and Isoniazid in people with Tuberculosis, run by Centers for Disease Control and Prevention at 8 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Tuberculosis
What is being tested?
Moxifloxacin and Isoniazid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
8 sitesin 3 countries
Study dates
Jul 2004to Aug 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

8 sites in 3 countries.

8 sites in 3 countries

United States6 sites

  • Johns Hopkins University

    Baltimore, Maryland, 21231

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • University of North Texas Health Science Center

    Fort Worth, Texas, 76104

  • Houston Veterans Administration Medical Center

    Houston, Texas, 77030

  • University of Southern California Medical Center

    Los Angeles, California, 90033

  • Audie L Murphy Memorial Veterans Administration Medical Center

    San Antonio, Texas, 78284

Other trials in United States

Canada1 site

  • University of British Columbia

    Vancouver, British Columbia, V5Z 1L8

Other trials in Canada

Uganda1 site

  • Makerere University Medical School

    Kampala

Other trials in Uganda

About this study

Official title: TBTC Study 27/28 PK: Pharmacokinetic Issues in the Use of Moxifloxacin for Treatment of Tuberculosis

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.

Conditions
Tuberculosis
Being tested
Moxifloxacin, Isoniazid
Keywords
tuberculosis, TB
Medical subject headings
Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MoxifloxacinDrug

    400 mg po qd 5/7 days per week

  • IsoniazidDrug

    isoniazid 300 mg po qd 5/7 days per week

Study groups in NCT00164463
Study groupRoleWhat they receive
MoxifloxacinExperimentalMoxifloxacin 400 mg po qd given 5 of 7 days per week
Receives: Drug: Moxifloxacin
IsoniazidActive comparatorIsoniazid 300 mg po qd given 5/7 days per week
Receives: Drug: Isoniazid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare in healthy volunteers the pharmacokinetics of moxifloxacin alone versus moxifloxacin administered with rifampin.

    Measured: 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.

    Measured: study period

Secondary outcomes (7)

  1. Determine variation of moxifloxacin pharmacokinetics (PK) among patients with pulmonary TB during treatment.

    Measured: 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.

    Measured: 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

    Measured: study period

  4. Determine the association between polymorphisms of MDR1 genotype (P-glycoprotein) and rifampin PK parameters.

    Measured: 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).

    Measured: study period

  6. Determine the effects of polymorphisms of MDR1 and UGT genotypes on moxifloxacin PK parameters.

    Measured: study period

  7. Determine by multivariate regression analyses the associations between moxifloxacin or rifampin PK parameters and markers of disease severity.

    Measured: study period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2005 (estimated)
  2. Study startJul 2004
  3. Primary completionAug 2007
  4. Study completionAug 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00164463
Sponsor's protocol ID
CDC-NCHSTP-4222
Status last verified
Jun 2011
First submitted
10 Sep 2005
Last updated
8 Jun 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Weiner M, Peloquin C, Burman W, Luo CC, Engle M, Prihoda TJ, Mac Kenzie WR, Bliven-Sizemore E, Johnson JL, Vernon A. Effects of tuberculosis, race, and human gene SLCO1B1 polymorphisms on rifampin concentrations. Antimicrob Agents Chemother. 2010 Oct;54(10):4192-200. doi: 10.1128/AAC.00353-10. Epub 2010 Jul 26.

    PubMed 20660695

  • Weiner M, Burman W, Luo CC, Peloquin CA, Engle M, Goldberg S, Agarwal V, Vernon A. Effects of rifampin and multidrug resistance gene polymorphism on concentrations of moxifloxacin. Antimicrob Agents Chemother. 2007 Aug;51(8):2861-6. doi: 10.1128/AAC.01621-06. Epub 2007 May 21.

    PubMed 17517835

  • Weiner M, Gelfond J, Johnson-Pais TL, Engle M, Peloquin CA, Johnson JL, Sizemore EE, Mac Kenzie WR. Elevated Plasma Moxifloxacin Concentrations and SLCO1B1 g.-11187G>A Polymorphism in Adults with Pulmonary Tuberculosis. Antimicrob Agents Chemother. 2018 Apr 26;62(5):e01802-17. doi: 10.1128/AAC.01802-17. Print 2018 May.

    PubMed 29463526

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Moxifloxacin and Isoniazid in people with Tuberculosis, run by Centers for Disease Control and Prevention at 8 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Canada, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare in healthy volunteers the pharmacokinetics of moxifloxacin alone versus moxifloxacin administered with rifampin. (time frame: study period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00164463, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2011; AzTrials last refreshed its copy on 8 Nov 2026.

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