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

NCT00682721 | Withdrawn

• 1 other identifier: PRO 08090230
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Bacterial Vaginosis; Herpes Simplex Virus Type II

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The frequency of detection of HSV-2 in the lower genital tract at the follow up visits.

  within 90 days of enrollment

Study Arms (2)

2

ACTIVE COMPARATOR

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

Drug: Valacyclovir

1

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

Matching placebo two pills once daily

1

Valacyclovir DRUG

1 gram daily x number of days active in the study

2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Thomas L Cherpes, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 16, 2008
• First Posted: May 22, 2008
• Study Start: February 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: March 2, 2012

Record last verified: 2012-02

Locations

US (1)