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The study is designed to assess the efficacy and safety of famciclovir 250 mg twice a day (bid) suppressive treatment in men and women with herpes virus type 2 (HSV-2) infection, with and without a reported history of genital herpes and with or without herpes virus type 1 (HSV-1) seropositivity.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Famciclovir | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Group 1. Reduction of HSV DNA PCR positive days in HSV-2 seropositive patients with a history of clinical genital herpes lesions | ||
| Group 2. Reduction of HSV DNA PCR positive days in HSV-2 seropositive patients without a history of clinical genital herpes lesions |
| Measure | Description | Time Frame |
|---|---|---|
| reduction of HSV DNA PCR positive days without lesions in HSV-2 seropositive patients with and without a history of clinical genital herpes lesions | ||
| quantitative HSV DNA PCR, during the days with positive HSV-2 shedding. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Orlando Clinical Research Center |
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| ID | Term |
|---|---|
| D006558 | Herpes Genitalis |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077595 | Famciclovir |
| ID | Term |
|---|---|
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| time to the first recurrence of genital herpes and number of genital herpes recurrence episodes |
| oral HSV-1 and/or HSV-2 shedding in HSV-1 and HSV-2 seropositive patients |
| reduction of HSV DNA PCR positive days with lesions in HSV-2 seropositive patients with and without a history of clinical genital herpes lesions |
| Orlando |
| Florida |
| 32809 |
| United States |
| IU Center for Clinical STD Research | Indianapolis | Indiana | 46202 | United States |
| UNC Clinical Research - Raleigh | Raleigh | North Carolina | 27607 | United States |
| Lynne Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Westover Heights Clinic | Portland | Oregon | 97210 | United States |
| University of Washington - Virology Research Clinic | Seattle | Washington | 98122 | United States |
| D006561 | Herpes Simplex |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| D006571 |
| Heterocyclic Compounds |