Status:
COMPLETED
Study of Daily Rifapentine for Pulmonary Tuberculosis
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
University of Cape Town Lung Institute
University of Cape Town
Conditions:
Tuberculosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this Phase 2 study is to determine the microbiological activity and safety of rifapentine when given as a component of multidrug intensive phase treatment of smear-positive pulmonary tuber...
Detailed Description
Prospective phase II, open-label, single center study in which each experimental rifapentine regimen is evaluated using a two-stage design. Adults (HIV-negative, or HIV-positive with CD4 \> 200 cells/...
Eligibility Criteria
Inclusion
- Suspected pulmonary tuberculosis with acid-fast bacilli in a stained smear of expectorated sputum. Patients having extra-pulmonary manifestations of tuberculosis, in addition to smear-positive pulmonary disease, are eligible for enrollment.
- No prior history of tuberculosis disease or tuberculosis treatment
- No treatment with fluoroquinolones in the 2 months preceding initiation of study drugs.
- Age \> 18 years
- Weight ≥ 50 kg and ≤ 80 kg
- Karnofsky score of at least 60 (requires occasional assistance but is able to care for most of his/her needs; see Appendix)
- Signed informed consent
- Ability to adhere with study follow-up
- Women with child-bearing potential must agree to practice an adequate (barrier) method of birth control or to abstain from heterosexual intercourse during study therapy.
- HIV negative, or HIV-positive with CD4 \> 200 cells/cu mm
- Laboratory parameters done at, or 14 days prior to, screening (with results available for review by study personnel):
- Serum alanine aminotransferase (ALT) activity ≤ 2 times the upper limit of normal
- Serum total bilirubin level ≤ 2 times the upper limit of normal
- Serum creatinine level less than or equal to the upper limit of normal
- Hemoglobin level of at least 7.0 g/dL
- Platelet count of at least 100,000/mm3
- Negative pregnancy test (women of childbearing potential)
Exclusion
- Pregnant or breast-feeding
- Known intolerance or allergy to any of the study drugs
- Concomitant disorders or conditions for which isoniazid (INH), rifamycins, pyrazinamide (PZA), or ethambutol (EMB) are contraindicated. These include severe hepatic damage, acute liver disease of any cause, and acute uncontrolled gouty arthritis.
- Current or planned therapy, during the intensive phase of TB therapy with cyclosporine or tacrolimus, or HIV antiretroviral (ARV) therapy, which have unacceptable interactions with rifamycins.
- Any medical or psychosocial condition, which, in the view of the study investigator, makes study participation inadvisable.
- Pulmonary silicosis
- Central nervous system TB
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT00814671
Start Date
April 1 2010
End Date
September 1 2014
Last Update
February 6 2018
Active Locations (1)
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1
Universiy of Cape Town Lung Institute
Cape Town, Western Cape, South Africa, 7937