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

NCT ID: NCT00682721

Last Updated: 2012-03-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2010-09-30

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.

Conditions

Bacterial Vaginosis; Herpes Simplex Virus Type II

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

2

Valacyclovir 1 gm daily x number of days active in the study

Group Type: ACTIVE_COMPARATOR

Valacyclovir

Intervention Type: DRUG

1 gram daily x number of days active in the study

1

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo two pills once daily

Interventions

Placebo

Matching placebo two pills once daily

Intervention Type: DRUG

Valacyclovir

1 gram daily x number of days active in the study

Intervention Type: DRUG

Eligibility Criteria

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)

• 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

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Thomas L. Cherpes, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas L Cherpes, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PRO 08090230

Identifier Type: -

Identifier Source: org_study_id