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

• Status: Withdrawn
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Treatments: Acyclovir; Valacyclovir

Criteria

Screening 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 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