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Sponsored by: |
University of Pittsburgh |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00682721 |
This study will evaluate the effect of daily valacyclovir suppression (versus placebo) on genital shedding of the herpes virus in women who have BV. Suppression means giving medication regularly to attempt to stop the shedding of the virus. All women will also be treated with a one-week course of oral (by outh) metronidazole to treat the BV. The active medications for this study (valacyclovir and metronidazole) are standard treatments for herpes suppression and BV, respectively, and are Center for Disease Control (CDC) approved medications for the treatment of these infections.
Condition | Intervention |
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Bacterial Vaginosis Herpes Simplex Virus Type II |
Drug: Placebo Drug: Valacyclovir |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Valacyclovir for the Reduction of HSV-2 and BV Recurrence Rates |
Estimated Enrollment: | 270 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Active Comparator
Valacyclovir 1 gm daily x number of days active in the study
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Drug: Valacyclovir
1 gram daily x number of days active in the study
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1: Placebo Comparator |
Drug: Placebo
Matching placebo two pills once daily
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Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Pre-Screening Inclusion Criteria:
Screening Inclusion Criteria:
Enrollment Inclusion Criteria:
Women who meet the following Amsel (by investigator assessment) and Nugent Criteria for the diagnosis of BV 3 or more Amsel criteria
Nugent criteria:
1. Vaginal gram stain score greater than or equal to 4 Subjects will be enrolled based on the Amsel criteria alone. Nugent scores will be performed to confirm the diagnosis of BV. Women whose gram stain is less than 4 will be replaced.
Pre-screening Exclusion Criteria:
Screening Exclusion Criteria:
Enrollment Exclusion Criteria:
Contact: Ingrid Macio, PA-C | 412-641-5455 | imacio@mail.magee.edu |
Contact: Jamie Haggerty | 412-641-5378 | jhaggerty@mail.magee.edu |
United States, Pennsylvania | |
Magee-Womens Hospital of UPMC | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Thomas L Cherpes, MD | University of Pittsburgh |
Responsible Party: | University of Pittsburgh ( Thomas L. Cherpes, MD ) |
Study ID Numbers: | PRO 07110164 |
Study First Received: | May 16, 2008 |
Last Updated: | May 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00682721 |
Health Authority: | United States: Institutional Review Board |
Bacterial Vaginosis Herpes Simplex Virus Type II |
Herpes Simplex Bacterial Infections Skin Diseases Vaginitis Vaginal Diseases Recurrence Herpesviridae Infections |
Virus Diseases Genital Diseases, Female Valacyclovir Skin Diseases, Infectious Vaginosis, Bacterial DNA Virus Infections |
Skin Diseases, Viral Anti-Infective Agents Therapeutic Uses Antiviral Agents Pharmacologic Actions |