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Sponsors and Collaborators: |
University of Washington National Institutes of Health (NIH) |
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Information provided by: | University of Washington |
ClinicalTrials.gov Identifier: | NCT00495573 |
The purpose of the study is to evaluate the pattern of viral shedding after beginning treatment with acyclovir for a clinical recurrence of genital herpes and to compare it with the pattern of viral shedding during an untreated clinical recurrence of genital herpes.
Condition | Intervention |
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Genital Herpes |
Drug: acyclovir |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Half-Life and Pattern of Resolution of Herpes Simplex Virus Type 2 (HSV-2) Shedding After Beginning Acyclovir Treatment |
whole blood, genital swab specimens
Estimated Enrollment: | 40 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | July 2017 |
Groups/Cohorts | Assigned Interventions |
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1
HSV-2 seropositive subjects who will receive a 5-day course of acyclovir for treatment of a genital herpes recurrence.
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Drug: acyclovir
400 mg acyclovir, orally three times a day for 5 days
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2
HSV-2 seropositive subjects who will be observed during a genital herpes recurrence but not receive acyclovir.
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The purpose of the study is to evaluate the pattern of viral shedding after beginning treatment with acyclovir for a clinical recurrence of genital herpes and to compare it with the pattern of viral shedding during an untreated clinical recurrence of genital herpes.
Participants are asked to visit the University of Washington Virology Research Clinic for an initial screening appointment in which the clinician will ensure eligibility and informed consent will be obtained.
Participants who experience an outbreak during the next year will be asked to call the clinic at the beginning of their next outbreak. The clinician will arrange to admit the participant to the UW General Clinical Research Center (GCRC) for a 5-day hospitalization stay. During hospitalization, participants will take acyclovir (400mg 3 times daily) and genital swabs will be collected every 2 hours during the day and every 4 hours at night for 5 days. After the last swab has been taken, the study nurse at the GCRC will do a final genital exam and the participant will be discharged. Some participants will also be asked to enroll in a control arm during which the same procedures will be followed except they will not take acyclovir during the recurrence.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
HSV-2 seropositive men and women with a history of at least 3 clinical recurrences of genital herpes within the year prior to the screening visit.
Participants will be recruited from the community.
Inclusion Criteria:
Exclusion Criteria:
Contact: Karen Mark, MD, MPH | 206-720-4340 | kmark@u.washington.edu |
United States, Washington | |
University of Washington Virology Research Clinic | Recruiting |
Seattle, Washington, United States, 98122 | |
Contact: Selin Caka 206-720-4340 scaka@u.washington.edu | |
Principal Investigator: Karen Mark, MD, MPH |
Principal Investigator: | Karen Mark, MD, MPH | University of Washington |
Responsible Party: | University of Washington ( Karen Mark, MD, MPH / Principal Investigator ) |
Study ID Numbers: | 26224, P01 AI-30731, R01 AI050132 |
Study First Received: | June 29, 2007 |
Last Updated: | December 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00495573 History of Changes |
Health Authority: | United States: Institutional Review Board |
Genital Diseases, Female Virus Diseases Herpes Simplex Sexually Transmitted Diseases, Viral Acyclovir Herpes Genitalis |
Sexually Transmitted Diseases DNA Virus Infections Genital Diseases, Male Antiviral Agents Herpesviridae Infections |
Herpes Simplex Anti-Infective Agents Sexually Transmitted Diseases, Viral Herpes Genitalis Genital Diseases, Male Antiviral Agents Pharmacologic Actions |
Herpesviridae Infections Virus Diseases Genital Diseases, Female Acyclovir Therapeutic Uses Sexually Transmitted Diseases DNA Virus Infections |