To compare the global clinical response of posaconazole (POS) compared to voriconazole (VOR) in the first line treatment of invasive aspergillosis (IA) at Week 6 in those subjects with proven or probable IA. The hypothesis to be tested is that the proportion of subjects achieving the global clinical response at Week 6 in the POS treatment group is noninferior to that in the VOR treatment group.
POS was shown to be effective in an open label, externally controlled salvage therapy trial of 107 patients with proven/probable aspergillosis.
- Subjects will be randomly assigned (in a 1:1 ratio) to receive either POS or VOR
- Each subject will participate in the trial for approximately 24 weeks from the time the subject signs the Informed Consent Form (ICF) through the final contact. After a screening phase of up to 7 days, each subject will be receiving assigned treatment for a maximum of 12 weeks. In general, most subjects should receive the full 12 weeks of study therapy. After the end of treatment each subject will be followed for 12 weeks post therapy (with a 1-month and 3-month post therapy follow-up visits).
Key eligibility:
- Men and women age must be ≥18 years of age weighing >40 kg [88 lb] and ≤150 kg [330 lb]
- Possible, probable, or proven IA (an invasive fungal infection that attacks your body)
- Detailed eligiblity will be reviewed when you contact the study team