Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00495573
Status:
COMPLETED
Last Update Posted:
2012-03-22
First Post:
2007-06-29
Brief Title:
HSV-2 Shedding Resolution After Acyclovir Treatment
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Half-life and Pattern of Resolution of Herpes Simplex Virus Type 2 HSV-2 Shedding After Beginning Acyclovir Treatment
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AI050132 | NIH | None | httpsreporternihgovquickSearchR01AI050132 |
| P01AI030731 | NIH | None | None |