HSV-2 Shedding Resolution After Acyclovir Treatment
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Purpose
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 |
|---|---|
|
Genital Herpes |
Drug: acyclovir |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Half-life and Pattern of Resolution of Herpes Simplex Virus Type 2 (HSV-2) Shedding After Beginning Acyclovir Treatment |
- To calculate the half-life of detectable HSV-2 DNA in genital mucosa during a clinical recurrence of genital herpes, after treatment with acyclovir has begun. [ Time Frame: 5 days ] [ Designated as safety issue: No ]
- To describe the time course, diurnal variation, and pattern of resolution of HSV-2 shedding during both acyclovir-treated and untreated clinical recurrences of genital herpes. [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
whole blood, genital swab specimens
| Enrollment: | 36 |
| Study Start Date: | June 2007 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
HSV-2 seropositive subjects who will receive a 5-day course of acyclovir for treatment of a genital herpes recurrence.
|
Drug: acyclovir
400 mg acyclovir, orally three times a day for 5 days
|
|
2
HSV-2 seropositive subjects who will be observed during a genital herpes recurrence but not receive acyclovir.
|
Detailed Description:
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.
Eligibility| 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:
- Age 18 years or older
- History of clinically-evident genital herpes
- 3 or more clinical genital herpes recurrences within the prior 12 months
- HSV-2 seropositive by HSV Western Blot
- Willing and able to comply with study protocol
Exclusion Criteria:
- Pregnancy
- Taking daily antiviral therapy for genital herpes
- HIV seropositive or known immunocompromising medical condition
- Plan to move from the Seattle area within the next year
- Hypersensitivity to or intolerance of acyclovir
Contacts and Locations| United States, Washington | |
| University of Washington Virology Research Clinic | |
| Seattle, Washington, United States, 98104 | |
| Principal Investigator: | Anna Wald, MD, MPH | University of Washington |
More Information
No publications provided
| Responsible Party: | Anna Wald, Principal Investigator, University of Washington |
| ClinicalTrials.gov Identifier: | NCT00495573 History of Changes |
| Other Study ID Numbers: | 26224-A, P01 AI-30731, R01 AI050132 |
| Study First Received: | June 29, 2007 |
| Last Updated: | March 21, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Herpes Genitalis Herpes Simplex Herpesviridae Infections DNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Genital Diseases, Male Genital Diseases, Female Acyclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013