pos vs flu for first line treatment of coccidioidomycosis (study p04558am1)(completed)

Conditions: Coccidioidomycosis

Summary: to evaluate the safety of posaconazole (pos) in the treatment of coccidioidomycosis. period a consisted of 2 blinded arms, posaconazole and fluconazole. recruitment was stopped, and participants in period a may have been eligible to roll over to an open-label, non-comparitive period b. during period b, participants received posaconazole for a treatment duration not to exceed 12 months.


Eligibility criteria:
inclusion criteria: * thirteen years of age or older, 34 kg (75 lb) or more, either sex, and any race; * coccidioides immitis (c. immitis) or coccidioides posadasii (c. posadasii) identified by culture or microscopic examination from skeletal disease, chronic active pulmonary disease, or soft tissue disease; * coccidioidomycosis score of \>=6; * clinical laboratory safety tests within normal limits or clinically acceptable to the sponsor; * free of any clinically significant disease that would interfere with study evaluations; * willing to give written informed consent and able to adhere to study medication dose, mandatory procedures (including human immunodeficiency virus (hiv) testing), and visit schedules; * able to swallow food or a nutritional supplement; * use of a medically accepted method of contraception; * negative serum pregnancy test at screening and negative urine pregnancy test at randomization; * women of childbearing potential not currently sexually active must agree to use a medically accepted method of contraception should they become sexually active while participating in the study. exclusion criteria: * key exclusion criteria excluded medications at enrollment * medications that are known to interact with pos or flu and that may lead to serious or life threatening side effects within 7 days prior to initiating study drug; * medications known to lower the serum concentration/efficacy of azole antifungals within 7 days prior to study drug start; * prior investigational drug use or biologic product administration within 30 days before study drug start; * prior antifungal treatment for the current episode of infection with a total cumulative dose of \>=8 g of any azole, \>=4 mg/kg of amphotericin b deoxycholate, or \>=20 mg/kg of lipid amphotericin b; * antiretrovirals that are substrates of cyp3a4 administered to hiv-positive subjects, as it is not currently known how pos or flu may affect such drugs or the potential to cause adverse reactions. * excluded concomitant conditions * immediately life-threatening coccidioidomycosis; * confirmed or suspected meningeal coccidioidomycosis; * pulmonary coccidioidomycosis in hiv-negative subjects for less than 3 months; * any condition requiring use of prohibited drugs; * cluster of differentiation 4 (cd4) count of \<200 cells/mm3 or any auto-immune deficiency syndrome (aids)-defining illness in hiv-positive subjects in the prior 30 days. * excluded baseline laboratory studies * moderate or severe liver dysfunction (aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> 5 times upper limit of normal (uln)) or a total bilirubin level or direct bilirubin \> 3 times uln plus alt or ast \>2 times uln (hy's rule); * moderate or severe renal dysfunction (creatinine clearance (crcl) \<20 ml/min) or dialysis required or expected to be required within the study period; * electrocardiogram (ecg) with a prolonged qtc interval by manual reading: qtc \>450 msec for males and qtc \>470 msec for females. * general exclusion criteria * prior enrollment in this study or other pos studies; * failed treatment with flu or pos at any time in the past; * history of hypersensitivity or idiosyncratic reactions to azole drug therapy; * women who are pregnant, intend to become pregnant, or are breast-feeding; * situation or condition that may interfere with optimal participation in the study; part of the staff personnel directly involved with this study; * family member of the investigational study staff.