Ignite Creation Date:
2025-12-25 @ 3:14 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT00808405
Status:
COMPLETED
Last Update Posted:
2013-12-11
First Post:
2008-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women
Sponsor:
University of Washington
Organization:
Study Overview
Official Title:
Prospective Study of Pharmacokinetics, Clinical and Virologic Response to Acyclovir Episodic Therapy for Genital Herpes Ulcers in HIV Negative African Women
Status:
COMPLETED
Status Verified Date:
2013-11
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:
PK/GUD
Brief Summary:
To examine the time to healing of genital lesion and duration of herpes simplex virus (HSV) shedding from genetic ulcer disease (GUD) among 90 HIV-negative African women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative randomized in a 2:1 ratio to receive episodic acyclovir 400mg orally three times daily or matching placebo three times daily for 5 days and who are followed for a total of 13 days.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U01AI052054 | NIH | None | https://reporter.nih.gov/quic… | View |