Check the boxes corresponding to any of the inclusion criteria the subject failed.
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Subject is in overall general good health. (1)
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Subject is a male or female who is 18 years of age or older. (2)
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A female is eligible to enter and participate in this study if she is of: non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre-menarchal or post-menopausal or surgically sterile); or child-bearing potential, has a negative pregnancy test (urine) at screen and agrees to one of the following: Complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period of 1 week after study completion or premature discontinuation from the study (to account for elimination of the drug), Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject, Implants of levonorgestrel, Injectable progestogen, Oral contraceptive (either combined or progestogen only), Any intrauterine device (IUD) with a documented failure rate of less than 1 % per year, Spermacide plus a mechanical barrier (condom/diaphragm) with a documented failure rate of less than 1 % per year. (3)
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Subject must have been previously diagnosed with HSV-2 genital herpes and have a history of at least 6 recurrences per year in the absence of suppressive antiherpetic therapy. Subject can enroll in the study as soon as three days (72 hours) after completing treatment for a recurrence. (4)
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Subject must be willing and able to provide written informed consent and comply with the protocol. (5)
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Subject must be HSV-2 seropositive at screening (6)
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Subject must have been previously diagnosed with HSV-2 genital herpes and have a history of at least 6 recurrences per year in the absence of suppressive antiherpetic therapy. Subject can enroll in the study as soon as three days (72 hours) after completing treatment for a recurrence. (4)
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Subject must be willing and able to provide written informed consent and comply with the protocol. (5)
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Subject must be HSV-2 seropositive at screening (6)
Check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry
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Subject is known or suspected to be immunocompromised (e.g., subjects receiving immunosuppressive therapy, or chemotherapy for malignancy, or are seropositive for HIV). (1)
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Subject who previously received an investigational drug in the 30 days prior to the study. (2)
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Subject who previously received an investigational drug in the 30 days prior to the study. (2)
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Subject is receiving systemic antiviral or immunomodulatory treatments. Subjects must not have received systemic antiherpetic treatments (e.g., VALTREX®, Famvir®, acyclovir, lysine) within 3 days of starting study drug or immunomodulatory treatments in the 30 days before starting study drug (3)
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Subject has clinically significant impaired hepatic function defined as an ALT (alanine transaminase) level > 5 times the normal upper limit. Also, subjects with active liver disease are not acceptable for enrollment. (5)
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Subject is known to be hypersensitive to acyclovir, famciclovir or ganciclovir or any component of VALTREX formulations. (6)
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Subject has clinically significant impaired renal function as defined by creatinine clearance less than 30ml/min (calculated using the Cockcroft-Gault formula). (4)
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Subject has malabsorption or vomiting syndrome or other gastrointestional dysfunction that might impair drug pharmacokinetics. (8)
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Subject has clinically significant impaired hepatic function defined as an ALT (alanine transaminase) level > 5 times the normal upper limit. Also, subjects with active liver disease are not acceptable for enrollment. (5)
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Women who are pregnant and/or nursing mothers. (10)
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Subjects with a current history of alcohol or drug abuse. (11)
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Subject is known to be hypersensitive to acyclovir, famciclovir or ganciclovir or any component of VALTREX formulations. (6)
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Subject is known to have an HSV infection that is resistant to acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir or valganciclovir. (7)
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Subject has malabsorption or vomiting syndrome or other gastrointestional dysfunction that might impair drug pharmacokinetics. (8)
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Women contemplating pregnancy within the duration of the study drug dosing period. (9)
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Women who are pregnant and/or nursing mothers. (10)
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Subjects with a current history of alcohol or drug abuse. (11)