Status:
COMPLETED
POS vs FLU for First Line Treatment of Coccidioidomycosis (Study P04558Am1)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Coccidioidomycosis
Eligibility:
All Genders
13+ years
Phase:
PHASE3
Brief 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 Pe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00423267
Start Date
May 1 2007
End Date
May 1 2009
Last Update
April 11 2017
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