Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients

Completed · Phase 4 · Has a placebo group

Conditions studied: Genital Herpes

In brief

This study will evaluate the safety and efficacy of single-day famciclovir episodic treatment in Black patients with recurrent genital herpes

Key facts

Study ID

NCT00477334

Run by

Novartis

People needed

463

Starts

2007-06-01

Expected to finish

2009-03-01

Last updated by the study team

2011-03-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Black men or women 18 years or older
• History of recurrent genital herpes with at least 4 recurrences in preceding 12 months or in preceding 12 months prior to using suppressive antiviral therapy
• Documented herpes simplex virus type 2 (HSV-2) seropositivity
• Willingness to discontinue suppressive therapy during study, if applicable
• Willingness and ability to comply with the study protocol

You may not qualify if…

• 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
• Known or suspected to have decompensated liver disease
• Known to have gastrointestinal malabsorption
• Known to be immunocompromised
• Known to be hypersensitive to ingredients in study medication
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Providence Clinical Research — Burbank, California, United States
• Alia Clinical Research, INC — Huntington Park, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• The Conant Foundation Quest Diagnostics — San Francisco, California, United States
• Medical Research Centers of South Florida, Inc. — Hollywood, Florida, United States
• First Coast Primary Care Minority Physicians Research Alliance — Jacksonville, Florida, United States
• AppleMed Research Inc. — Miami, Florida, United States
• International Research Associates, LLC — Miami, Florida, United States
• Segal Institute for Clinical Research Heathcare Clinical Data, Inc — North Miami, Florida, United States
• Perimeter Institute for Clinical Research Inc. ("PICR") — Atlanta, Georgia, United States
• Medical College of Georgia Hospital and Clinics — Augusta, Georgia, United States
• Soapstone Center for Clinical Research — Decatur, Georgia, United States
• Mount Vernon Clinical Research, LLC — Sandy Springs, Georgia, United States
• Clinical Trials Management LLC — Covington, Louisiana, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• Omni Fertility and Laser Institute — Shreveport, Louisiana, United States
• International Research Center — Towson, Maryland, United States
• Miray Medical Center — Brockton, Massachusetts, United States
• Pearl Medical Group, PLLC — Southfield, Michigan, United States
• Dr. Mohammed — St Louis, Missouri, United States
• Nevada Alliance Against Diabetes — Las Vegas, Nevada, United States
• Metrolina Internal Medicine Internal Medicine Research — Charlotte, North Carolina, United States
• Peters Medical Research — High Point, North Carolina, United States
• UNC Clinical Research — Raleigh, North Carolina, United States
• Hawthorne Medical Research, Inc. — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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