|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | University of Pittsburgh |
|---|---|
| Information provided by: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00682721 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Bacterial Vaginosis Herpes Simplex Virus Type II |
Drug: Placebo Drug: Valacyclovir |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Valacyclovir Suppression to Improve the Stability of Vaginal Flora Among HSV-2 Seropositive Women |
| Estimated Enrollment: | 1000 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
2: Active Comparator
Valacyclovir 1 gm daily x number of days active in the study
|
Drug: Valacyclovir
1 gram daily x number of days active in the study
|
| 1: Placebo Comparator |
Drug: Placebo
Matching placebo two pills once daily
|
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Screening Inclusion Criteria:
Screening Exclusion Criteria:
Enrollment Inclusion Criteria:
Enrollment Exclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |
| Magee-Womens Hospital of UPMC | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | Thomas L Cherpes, MD | University of Pittsburgh |
More Information
| Responsible Party: | University of Pittsburgh ( Thomas L. Cherpes, MD ) |
| Study ID Numbers: | PRO 08090230 |
| Study First Received: | May 16, 2008 |
| Last Updated: | September 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00682721 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Bacterial Vaginosis Herpes Simplex Virus Type II |
|
Herpes Simplex Bacterial Infections Anti-Infective Agents Skin Diseases Vaginitis Vaginal Diseases Antiviral Agents Pharmacologic Actions Herpesviridae Infections |
Virus Diseases Skin Diseases, Viral Genital Diseases, Female Valacyclovir Skin Diseases, Infectious Vaginosis, Bacterial Therapeutic Uses DNA Virus Infections |