Tuberculosis Clinical Trial
Official title:
A Phase 2 Randomized, Open-label Trial of Daily Rifapentine 450mg or 600mg in Place of Rifampicin 600mg for Intensive Phase Treatment of Smear-positive Pulmonary Tuberculosis
Verified date | January 2018 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 tuberculosis (TB).
Funding Source- FDA Office of Orphan Products Development (OOPD)
Status | Completed |
Enrollment | 153 |
Est. completion date | September 2014 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. 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. 2. No prior history of tuberculosis disease or tuberculosis treatment 3. No treatment with fluoroquinolones in the 2 months preceding initiation of study drugs. 4. Age > 18 years 5. Weight = 50 kg and = 80 kg 6. Karnofsky score of at least 60 (requires occasional assistance but is able to care for most of his/her needs; see Appendix) 7. Signed informed consent 8. Ability to adhere with study follow-up 9. 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. 10. HIV negative, or HIV-positive with CD4 > 200 cells/cu mm 11. 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 Criteria: 1. Pregnant or breast-feeding 2. Known intolerance or allergy to any of the study drugs 3. 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. 4. 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. 5. Any medical or psychosocial condition, which, in the view of the study investigator, makes study participation inadvisable. 6. Pulmonary silicosis 7. Central nervous system TB |
Country | Name | City | State |
---|---|---|---|
South Africa | Universiy of Cape Town Lung Institute | Cape Town | Western Cape |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | University of Cape Town, University of Cape Town Lung Institute |
South Africa,
Rosenthal IM, Williams K, Tyagi S, Peloquin CA, Vernon AA, Bishai WR, Grosset JH, Nuermberger EL. Potent twice-weekly rifapentine-containing regimens in murine tuberculosis. Am J Respir Crit Care Med. 2006 Jul 1;174(1):94-101. Epub 2006 Mar 30. — View Citation
Rosenthal IM, Williams K, Tyagi S, Vernon AA, Peloquin CA, Bishai WR, Grosset JH, Nuermberger EL. Weekly moxifloxacin and rifapentine is more active than the denver regimen in murine tuberculosis. Am J Respir Crit Care Med. 2005 Dec 1;172(11):1457-62. Epu — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With Negative Lowenstein Jensen Cultures at Week 8 | 8 weeks | ||
Primary | Tolerability | percentage of participants discontinuing assigned treatment | 10 weeks | |
Secondary | Time to Stable Culture Conversion on Solid Medium | Time to stable culture conversion (in days) on Lowenstein Jensen solid medium | 12 weeks | |
Secondary | Time to Stable Culture Conversion on Liquid MGIT Media | Time (in days) to stable culture conversion on liquid MGIT media | 12 weeks | |
Secondary | Pharmacokinetics of Rifapentine | area under the concentration time curve (AUC[0-24]) for rifapentine administered once daily at doses of 450 mg or 600 mg in the context of multi drug intensive phase TB treatment | 8 weeks |
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