HSV-2 Shedding Resolution After Acyclovir Treatment | NCT00495573

Studies
HSV-2 Shedding Resolution After Acyclovir Treatment

NCT00495573

Sponsor

University of Washington

Status

Completed

Last Update Posted

Mar 22, 2012Estimated

Enrollment

36Actual

Phase

Not provided

Conditions

Genital Herpes

Interventions

acyclovir

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
P01AI030731	U.S. NIH Grant/Contract		View source
R01AI050132	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Nov 2009Actual

Completion Date

Mar 2012Actual

First Submitted Date

Jun 29, 2007

First Submission Date that Met QC Criteria

Jul 2, 2007

First Posted Date

Jul 3, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2012

Last Update Posted Date

Mar 22, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Anna Wald, Principal Investigator, University of WashingtonPrincipal Investigator

Lead Sponsor

University of WashingtonOTHER

Collaborators

Name	Class
National Institutes of Health (NIH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		HSV-2 seropositive subjects who will receive a 5-day course of acyclovir for treatment of a genital herpes recurrence.	Drug: acyclovir
2		HSV-2 seropositive subjects who will be observed during a genital herpes recurrence but not receive acyclovir.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
acyclovir	Drug	400 mg acyclovir, orally three times a day for 5 days	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.		5 days

Secondary Outcomes

Measure	Description	Time Frame
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.		5 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anna Wald, MD, MPH	University of Washington	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Washington Virology Research Clinic		Seattle	Washington	98104	United States

Condition Browse Module

MeSH Terms

ID	Term
D006558	Herpes Genitalis

Ancestor Terms

ID	Term
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000212	Acyclovir

Ancestor Terms

ID	Term
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D006574

Browse Leaves

Not provided

Browse Branches

Not provided