Valacyclovir Suppression to Improve the Stability of Vaginal Flora Among HSV-2 Seropositive Women

Not Applicable

Withdrawn

• Conditions: Bacterial Vaginosis; Herpes Simplex Virus Type II
• Interventions: Drug: Valacyclovir; Drug: Placebo

• Registration Number: NCT00682721
• Lead Sponsor: University of Pittsburgh

Brief Summary

We will be examining the effects of suppressive valacyclovir therapy on the stability of vaginal flora in women who are seropositive for HSV-2. We have preliminary data that suggests the presence of HSV-2 increases the risk for Group B Streptococcus colonization as well as many other deleterious organisms (e.g. Streptococcus pseudoporcinus), in addition to increasing the risk for acquisition of BV-associated vaginal flora. We will be examining the effects of suppressive therapy on the vaginal flora of any HSV-2 seropositive woman.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-05-16
• Study First Submitted QC: 2008-05-21
• Study First Posted: 2008-05-22
• Study Start: 2009-02
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-29
• Last Update Posted: 2012-03-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Women 18-40 years of age at the time of screening
• Willing to be screened for HSV-2 using a rapid, FDA approved test
• Using an effective method of birth control (examples of effective methods of birth control are: women practicing abstinence x 90 days, hormonal birth control, consistent condom use, bilateral tubal ligation, partner with a vasectomy)

Screening

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Exclusion Criteria

• Pregnant or nursing mother
• Use of any antimicrobial agents (vaginal or systemic) for the treatment of any condition within 7 days
• Presence of any intrauterine device
• Allergy or hypersensitivity to valcyclovir or nucleoside analogues

Enrollment Inclusion Criteria:

• Women 18-40 Years of age at the time of screening
• HSV-2 seropositive as determined by rapid HSV-2 testing
• Using an effective method of birth control (examples of effective methods of birth control are: women practicing abstinence x 90 days, hormonal birth control, consistent condom use, bilateral tubal ligation, partner with a vasectomy)
• Willing to avoid use of any intravaginal products during study period
• Capable of providing written informed consent
• Capable of cooperating to the extent and degree required by this protocol

Enrollment Exclusion Criteria:

• Pregnancy (all women will have a urine pregnancy test prior to randomization and treatment)
• nursing mother
• Menopausal women
• Use of any antimicrobial agents (vaginal or systemic) for the treatment of any condition within 7 days of study enrollment
• Known immunocompromised state
• Significant Medical disorder that precludes accurate evaluation of participants condition
• Presence of any intrauterine device
• History of significant hepatic or renal impairment
• Sensitivity/allergy to valacyclovir or nucleoside analogues
• history of acyclovir or valacyclovir resistant HSV infection
• Participation in a study using an investigational product in the past 30 days

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Valacyclovir	Valacyclovir 1 gm daily x number of days active in the study
1	Placebo	-

Primary Outcome Measures

Name	Time	Method
The primary endpoint of this study will be a determination of the ability of valacyclovir suppressive therapy to stabilize the vaginal flora.	within 90 days of enrollment

Secondary Outcome Measures

Name	Time	Method
The frequency of detection of HSV-2 in the lower genital tract at the follow up visits.	within 90 days of enrollment

Trial Locations

Locations (1)

Magee-Womens Hospital of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States