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| Sponsor: | University of Pittsburgh |
|---|---|
| Information provided by: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00464542 |
Purpose
An important contributor to the epidemic spread of herpes simplex virus type 2 (HSV-2) is its high frequency of asymptomatic shedding in the genital tract, as transmission usually occurs during these periods of subclinical reactivation of the virus (1). Therefore, an improved understanding of the risk factors associated with HSV-2 shedding is needed.
The researchers' preliminary data suggests that bacterial vaginosis (BV) may be associated with increased genital tract shedding of HSV-2 (2). As BV is the most common cause of vaginal symptoms in reproductive age women, even modest associations with genital tract shedding of HSV-2 would result in substantial attributable risks for transmission of the virus.
The researchers' investigation will assess the effects of asymptomatic BV on daily genital tract shedding of HSV-2 by determining shedding frequency before and after treatment of asymptomatic BV. To do this, the researchers will enroll 35 HSV-2 seropositive women with asymptomatic BV. These women will be instructed to self-collect daily swab specimens for HSV-2 DNA PCR analysis from the lower genital tract for one month. At the end of the one month follow-up visit, each participant will complete a one week course of oral metronidazole for treatment of BV. This will be followed by daily home collection of genital tract swab specimens for an additional one month.
| Condition | Intervention | Phase |
|---|---|---|
|
Bacterial Vaginosis |
Drug: metronidazole |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Crossover Assignment, Efficacy Study |
| Official Title: | Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 Shedding |
| Estimated Enrollment: | 35 |
| Study Start Date: | December 2007 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: metronidazole
po, 500 mg, BID, 7 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 26 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
It has been reported that 50% of women who meet clinical criteria for BV will deny symptoms (12).
In addition, routine antimicrobial treatment of women with asymptomatic BV is not currently recommended by the Centers for Disease Control (13).
Exclusion Criteria:
Contacts and Locations| Contact: Thomas L Cherpes, MD | 412 641 1999 | cherpestl@upmc.edu |
| United States, Pennsylvania | |
| University of Pittsburgh | Not yet recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| University of Pittsburgh, Magee Womens Hospital | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15237 | |
| Principal Investigator: | Thomas L Cherpes | Univerisity of Pittsburgh |
More Information
| Responsible Party: | University of Pittsburgh ( Thomas L. Cherpes ) |
| Study ID Numbers: | PRO07030124 |
| Study First Received: | April 19, 2007 |
| Last Updated: | October 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00464542 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
herpes simplex virus |
|
Herpes Simplex Bacterial Infections Anti-Infective Agents Metronidazole Antiprotozoal Agents Skin Diseases Physiological Effects of Drugs Vaginitis Vaginal Diseases Pharmacologic Actions |
Herpesviridae Infections Virus Diseases Skin Diseases, Viral Genital Diseases, Female Antiparasitic Agents Skin Diseases, Infectious Vaginosis, Bacterial Radiation-Sensitizing Agents Therapeutic Uses DNA Virus Infections |