POS vs FLU for First Line Treatment of Coccidioidomycosis (Study P04558Am1)(COMPLETED)
POS vs FLU for First Line Treatment of Coccidioidomycosis (Study P04558Am1)(COMPLETED)
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.
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.