Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005663
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-05-11
Brief Title:
A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients
Sponsor:
Glaxo Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
An International Randomized Double-Blind Placebo-Controlled Study of Valacyclovir for the Suppression of Recurrent Ano-Genital HSV Infections in HIV-Infected Subjects
Status:
UNKNOWN
Status Verified Date:
2001-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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 this study is to see if valacyclovir Valtrex is a safe and effective treatment for ano-genital HSV infections herpes simplex virus infections of the anus and external genitals in HIV-infected patients
Detailed Description:
Patients are randomized in a 21 ratio to receive either Valtrex or placebo twice daily for up to 6 months Patients come to the clinic for routine monthly assessments for 6 months and return to the clinic for evaluation within 24 hours of the first signs or symptoms of an ano-genital HSV recurrence Once the clinician confirms the presence of at least the macularpapular lesion stage double-blind suppressive therapy is discontinued and open-label treatment with a higher dose of Valtrex twice daily for 5 days is initiated For the first recurrence patients are instructed to return to the clinic for further clinical assessments on Day 5 of the recurrence Patients who have not healed by Day 5 may be offered an additional five days of open-label treatment as deemed appropriate by the clinical investigator If an additional 5-day course of open-label treatment medication is dispensed the patient returns to the clinic on Day 10 for evaluation Patients who have not healed by Day 10 are managed as deemed appropriate by the investigator Once treatment of the first ano-genital HSV recurrence is complete and the patient is healed patients are switched to open-label suppressive therapy with Valtrex for the remainder of the study period up to a maximum of 6 months The total duration of the study for all patients is 6 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HS230018 | None | None | None |