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

Bacterial Vaginosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00682721
• Other study ID #: PRO 08090230
• Status: Withdrawn
• Phase: N/A
• First received: May 16, 2008
• Last updated: February 29, 2012
• Start date: February 2009
• Est. completion date: September 2010

Study information

• Verified date: February 2012
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Herpes Simplex
• Herpes Simplex Virus Type II
• Vaginosis, Bacterial

Intervention

Drug:
• Placebo
Matching placebo two pills once daily
• Valacyclovir
1 gram daily x number of days active in the study

Locations

Country	Name	City	State
United States	Magee-Womens Hospital of UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The frequency of detection of HSV-2 in the lower genital tract at the follow up visits.		within 90 days of enrollment	No