A PHASE 3 RANDOMIZED STUDY OF THE EFFICACY AND SAFETY OF POSACONAZOLE VERSUS VORICONAZOLE FOR THE TREATMENT OF INVASIVE ASPERGILLOSIS IN ADULTS (PHASE 3; PROTOCOL NO. MK-5592-069)

Gender: Both
Maximum age: 100
Minimum age: 18
Inclusion criteria:
1 Each subject must be willing and able to provide written informed consent for the trial.
2 Be ≥13 years of age & weigh >40 kg and ≤150 kg at V2 or between 13 - 14 years & weigh ≥ 50. Either sex and any race/ethnicity
3 Meet the criteria for proven, probable, or possible IA as per 2008 EORTC/MSG disease definitions at V2
4 Subject with possible IA at V2 must be or be in process of an ongoing diagnostic work up which is anticipated to result in mycological diagnosis of proven or probable IA within 7 days postV2
5 Central line in place prior to begin IV study therapy
6 Acute IA
7 Adhere to dosing, study visit schedule & mandatory procedures: study therapy for up to 12 weeks and remain for 3-month follow-up
8 Ability to transition to oral study therapy during the course of the study or to receive the entire 12-week study treatment course IV
9 Fertile female subjects use an accepted method of birth control (MBC) before beginning study-drug treatment and continue its use for 30d after stopping the medication, or have been surgically sterilized. Barrier MBC is necessary if using oral or injectable hormonal contraception. If currently not sexually active, use one of the above methods if they become sexually active while in the study
10 Written IC for the pharmacogenetic testing (if participate in pharmacogenetic analysis)
11 Subject is not taking prohibited antifungal prophylaxis or treatment as defined by the protocol.

Exclusion criteria:
1Chronic, relapsed/recurrent, or refractory IA which has not responded to prior antifungal treatment (tto)
2 Sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis
3 Mixed invasive mold fungal and/or invasive Aspergillus fungal infection where either study drug may not be considered active
4 Systemic antifungal therapy for 4 or more consecutive days prior to randomization.
5 IA infection during the receipt of more than 13 days of antifungal prophylaxis
6POS or VOR as empirical tto
7Prohibited tto more recent than washout period
8Condition that may interfere with study
9Hypersensitivity or other serious adverse reaction to azoles
10Female is pregnant or nursing
11History of arrhythmia or infaction
12QTc ≥ 500 msec
13 Liver dysfunction
14 Cirrhosis or Child-Pugh score of C
15 Renal insufficiency or on hemodialysis
16 Galactose intolerance, Lapp lactase deficiency, or GLU-GAL malabsorption
17 Prior acute symptomatic pancreatitis or chronic pancreatitis
18Active skin lesion consistent with squamous cell carcinoma or current or prior history of malignant melanoma
19Artificial ventilation
20Known or suspected Gilbert?s disease
21Tto with medication that cannot be stop and is contraindicated to coadministration of one or more of study drugs
22 Not wxpected to survive for at least 1 week postt-V2
23No prior enrollment in this or other POS study
24Subject or family member is among site or sponsor staff personnel