Status:
TERMINATED
Rifapentine Plus Moxifloxacin for Treatment of Pulmonary Tuberculosis
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Universidade Federal do Rio de Janeiro
Conditions:
Tuberculosis
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief Summary
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00728507
Start Date
November 1 2009
End Date
April 1 2013
Last Update
April 20 2017
Active Locations (3)
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1
Centro de Referência Professor Hélio Fraga - ENSP - FIOCRUZ
Curicica, Rio de Janeiro, Brazil, 22.780-192
2
Posto de Saude Albert Sabin
Rio de Janeiro, Rio de Janeiro, Brazil, 20211-110
3
Hospital Universitario Clementio Fraga Filho
Rio de Janeiro, Brazil