HSV-2 Shedding Resolution After Acyclovir Treatment

This study has been completed.

Sponsor:

Collaborator:

National Institutes of Health (NIH)

Information provided by (Responsible Party):

Anna Wald, University of Washington

ClinicalTrials.gov Identifier:

NCT00495573

First received: June 29, 2007

Last updated: March 21, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 29, 2007

Last Updated Date

March 21, 2012

Start Date ^ICMJE

June 2007

Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00495573 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

HSV-2 Shedding Resolution After Acyclovir Treatment

Official Title ^ICMJE

Half-life and Pattern of Resolution of Herpes Simplex Virus Type 2 (HSV-2) Shedding After Beginning Acyclovir Treatment

Brief Summary

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.

Detailed Description

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

whole blood, genital swab specimens

Sampling Method

Non-Probability Sample

Study Population

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.

Condition ^ICMJE

Genital Herpes

Intervention ^ICMJE

Drug: acyclovir

400 mg acyclovir, orally three times a day for 5 days

Study Group/Cohort (s)

1
HSV-2 seropositive subjects who will receive a 5-day course of acyclovir for treatment of a genital herpes recurrence.

Intervention: Drug: acyclovir
2
HSV-2 seropositive subjects who will be observed during a genital herpes recurrence but not receive acyclovir.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2012

Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00495573

Other Study ID Numbers ^ICMJE

26224-A, P01 AI-30731, R01 AI050132

Has Data Monitoring Committee

Responsible Party

Anna Wald, University of Washington

Study Sponsor ^ICMJE

University of Washington

Collaborators ^ICMJE

National Institutes of Health (NIH)

Investigators ^ICMJE

Principal Investigator:

Anna Wald, MD, MPH

University of Washington

Information Provided By

University of Washington

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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