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Rifapentine Plus Moxifloxacin for Treatment of Pulmonary Tuberculosis

This study has been terminated.
(Funding withdrawn)
Sponsor:
Collaborator:
Universidade Federal do Rio de Janeiro
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00728507
First received: July 30, 2008
Last updated: March 8, 2017
Last verified: March 2017
  Purpose

Although effective therapy for tuberculosis is available, TB continues to cause significant problems worldwide, and rates of multi-drug resistant (MDR) TB cases are on the rise. A major obstacle to the control of TB is poor adherence with lengthy (usually 6 months) and complicated treatment regimens. Incomplete TB treatment can lead to serious consequences such as increased severity of illness and death, prolonged infectiousness and transmission in the community, and the development of drug resistance. The development of new treatment strategies with more stronger drugs could lead to shorter and simpler regimens. A TB treatment regimen that allowed treatment duration to be meaningfully decreased would have important public health implications.

This trial will compare the effect and safety of a new oral regimen to that of the standard regimen for the first phase of treatment for pulmonary tuberculosis.

The experimental regimen will consist of the following:

  • Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.

The standard control intensive phase regimen will consist of the following:

  • Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.

Following intensive phase therapy (the study phase), all patients will be treated with a non-experimental continuation phase regimen.

In mice, the combination of Moxifloxacin and Rifapentine have cured the animals significantly faster than the standard regimen and this study will be the first step to see if the potential is also there in humans.


Condition Intervention Phase
Tuberculosis Drug: Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid Drug: Isoniazid, Rifampin, Pyrazinamide, Ethambutol Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase II Randomized, Open-label Trial of a Rifapentine Plus Moxifloxacin-Based Regimen for Intensive Phase Treatment of Smear-Positive Pulmonary Tuberculosis

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • To Compare, by Treatment Group, the Percentage of Patients With a Negative Sputum Culture at the End of Intensive Phase Therapy. [ Time Frame: Week 8 ]
    LJ culture conversion

  • To Compare the Safety and Tolerability of the 2 Intensive Phase Regimens. [ Time Frame: Weekly or more frequent ]
    Study was prematurely terminated and data was not collected for this outcome measure.


Enrollment: 121
Study Start Date: November 2009
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.
Drug: Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid
Rifapentine:150mg tablets, dose = 300mg for subjects <= 45kg and 450mg for those >45kg by mouth once a day for 8 weeks; Moxifloxacin 400mg tablet by mouth once a day for 8 weeks, Isoniazid and Pyrazinamide per standard of care for TB treatment.
Other Name: Priftin, Avelox
Active Comparator: 2
Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.
Drug: Isoniazid, Rifampin, Pyrazinamide, Ethambutol
Administered per standard of care for TB treatment

  Eligibility

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presumptive diagnosis of sputum smear-positive pulmonary TB.
  • Age: ≥18 years
  • Seven (7) or fewer days of multidrug therapy for TB disease in the preceding 6 months.
  • Seven (7) or fewer days of fluoroquinolone therapy in the preceding 3 months.
  • Documentation of HIV infection status.
  • For HIV seropositive individuals, a CD4 T lymphocyte count of greater than or equal to 200 cells/mm3.
  • Documentation of study baseline laboratory parameters done at, or ≤ 14 days prior to screening:

    • AST less than or equal to 2.5 times upper limit of normal.
    • Total bilirubin level less than 2.5 times upper limit of normal.
    • Creatinine level less than 2 times upper limit of normal.
    • Hemoglobin level of at least 8.0 g/dl.
    • Platelet count of at least 75,000 mm3.
    • Potassium level of at least 3.5.
    • Negative pregnancy test (women of childbearing potential).
  • Karnofsky score of at least 60 (requires occasional assistance but is able to care for most of his/her needs).
  • Male or nonpregnant, nonnursing female.
  • Provision of informed consent.

Exclusion Criteria:

  • CD4 count < 200 cells/cu mm.
  • Presence of active AIDS-related opportunistic infection (other than TB) or active AIDS-related malignancy.
  • Known intolerance to any of the study drugs.
  • Concomitant disorders or conditions for which any of the study drugs is contraindicated. These include severe hepatic damage, acute liver disease of any cause, and acute uncontrolled gouty arthritis.
  • Inability to take oral medication.
  • Central nervous system TB.
  • Pulmonary silicosis.
  • Current or planned therapy, during study phase (intensive phase of TB treatment), with any one or more of the following drugs: quinidine, procainamide, amiodarone, sotalol, disopyramide, terfenadine, cisapride, erythromycin, clarithromycin, phenothiazines, haloperidol, olanzapine, ziprasidone, tricyclic antidepressants, chronic corticosteroids administered either orally or intravenously, chronic fluconazole,chronic itraconazole, chronic ketoconazole, oral or intravenous tacrolimus, oral or intravenous cyclosporine, HIV protease inhibitor, HIV non-nucleoside reverse transcriptase inhibitor.
  • Concurrent severe and/or uncontrolled medical or psychiatric condition that, in the opinion of the investigator, could cause unacceptable safety risks or compromise compliance with the protocol.
  • Unable or unwilling to receive directly observed therapy and/or adhere with follow-up (e.g. due to residence remote from the study site).
  • Refusal of consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728507

Locations
Brazil
Centro de Referência Professor Hélio Fraga - ENSP - FIOCRUZ
Curicica, Rio de Janeiro, Brazil, 22.780-192
Posto de Saude Albert Sabin
Rio de Janeiro, RJ, Brazil, 20211-110
Hospital Universitario Clementio Fraga Filho
Rio de Janeiro, Brazil
Sponsors and Collaborators
Johns Hopkins University
Universidade Federal do Rio de Janeiro
Investigators
Principal Investigator: Susan Dorman, MD Johns Hopkins University
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00728507     History of Changes
Other Study ID Numbers: 06-0018
Study First Received: July 30, 2008
Results First Received: August 3, 2016
Last Updated: March 8, 2017

Keywords provided by Johns Hopkins University:
Tuberculosis
Moxifloxacin
Rifapentine

Additional relevant MeSH terms:
Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Moxifloxacin
Fluoroquinolones
Rifampin
Isoniazid
Pyrazinamide
Ethambutol
Rifapentine
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

ClinicalTrials.gov processed this record on July 27, 2017