Influenza Study

Inclusion criteria:

1. Ages 13 - 85; males and females
2. Present to the clinic with symptoms suggestive of a diagnosis of acute influenza and have at least 1 respiratory symptom (cough, sore throat, nasal congestion) and at least 1 systemic symptom (headache, body aches or pain, feverishness, fatigue)
3. Tested positive for influenza A
4. Not be in need of hospitalized medical care at screening
5. Enrollment and initiation of study drug treatment ≤72 hours after onset of influenza symptoms
6. Not of childbearing potential (premenarchal, postmenopausal, or permanently sterile)
7. Of childbearing potential and practicing a highly effective method of contraception
8. Negative pregnancy test
9. A woman must agree not to donate eggs during the study and for a period of at least 30 days after the last dose of study drug
10. A male must agree not to donate sperm
11. Subjects 13 to 65 years of age must also have one of the following:
12. Cardiovascular or cerebrovascular disease (including congenital heart disease, chronic hear failure, coronary artery disease, or stroke)
13. Chronic lung disease (asthma, chronic obstructive lung disease [COPD] or cystic fibrosis)
14. Weakened immune system due to disease or medication (subjects with human immunodeficiency virus [HIV], cancer or chronic liver or kidney disease, or subjects taking chronic systemic steroids)

Exclusion criteria:**

1. Received more than 1 dose of influenza antiviral medicine, or any dose of ribavirin 2 weeks prior to first study drug intake, or received IV peramivir more than 1 day prior to screening
2. Unwilling to undergo regular nasal MT swabs or any physical abnormality which limits the ability to collect regular nasal MT specimens
3. Unstable angina pectoris or myocardial infarction 30 days prior to screening
4. Presence of clinically significant heart arrhythmias, uncontrolled/unstable atrial arrhythmia or, sustained ventricular arrhythmia, or risk factors for Torsade de Pointes syndrome
5. Chronic hepatitis C infection
6. Known allergies, hypersensitivity, or intolerance to pimodivir or its excipients
7. Taken any investigational drug (including investigational vaccines) within 30 days of the study
8. A woman who is pregnant, breast feeding or planning to become pregnant while enrolled in the study
9. A man who plans to father a child while enrolled in the study