Patient-Initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients
Information source: Novartis
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Genital Herpes
Intervention: Famciclovir (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Dalu Mohammed, Dr, Principal Investigator, Affiliation: Clayton Research Institute
Overall contact:
Novartis, Phone: 8627788300
Summary
This study will evaluate the safety and efficacy of single-day famciclovir episodic treatment
in Black patients with recurrent genital herpes
Clinical Details
Official title: A Randomized, Multicenter, Double-Blind Study to Compare the Efficacy of Single-Day Treatment (1000 mg b.i.d.) With Famciclovir Compared to That of Placebo in Patient-Initiated Episodic Treatment of Recurrent Genital Herpes in Immunocompetent Black Patients
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Time to healing of non-aborted genital herpes lesions
Secondary outcome: • Safety as assessed by adverse events and laboratory abnormalities
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Black men or women 18 years or older
- History of recurrent genital herpes with at least 4 recurrences in preceding year
- Documented herpes simplex virus - 2 (HSV-2) seropositivity
- Willingness to discontinue suppressive therapy during study, if applicable
- Willingness and ability to comply with the study protocol
Exclusion Criteria:
- Pregnant or breastfeeding women
- Women of childbearing potential not using accepted methods of contraception
- Hypersensitivity to famciclovir or drugs with similar chemical structures
- Renal dysfunction
- Hepatic diseases Other protocol-defined inclusion/exclusion criteria may apply
Locations and Contacts
Novartis, Phone: 8627788300
Dr. Mohammed, St. Louis, Missouri 63117, United States; Recruiting
Mohammed, Phone: 314-647-5754
Additional Information
Click here for more information on this study
Starting date: June 2007
Last updated: March 6, 2008
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