Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002394
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment
Sponsor:
Novartis
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Four-Week Open-Label Non-Randomized Multicenter Dose-Finding Pilot Study to Evaluate the Safety and Efficacy of Two Daily Doses of Lamisil 1500 Mg and 2000 Mg Administered for a Maximum of 4 Weeks in HIV-Positive Subjects With Oral Mucosal Candidiasis Not Having Responded to a Minimum of 200 Mg Fluconazole Monotherapy
Status:
COMPLETED
Status Verified Date:
1999-12
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 this study is to see if it is safe and effective to give Lamisil to HIV-positive patients with thrush a fungal infection that has not responded to fluconazole
Detailed Description:
This is an open-label dose-escalating study with up to 2 sequential cohorts The first 15 patients receive Lamisil for 2 weeks After 2 weeks patients considered clinically cured ie absence of removable white plaques are removed from treatment patients not considered clinically cured receive an additional 2 weeks of treatment At the end of 4 weeks treatment is discontinued regardless of clinical cure outcome If less than 80 of patients are clinically cured after the 4 weeks of treatment a second cohort of 15 patients receive Lamisil on the same treatment regimen as first cohort ie initial 2-week treatment period with an additional 2 weeks of treatment for those patients who are not considered clinically cured after 2 weeks of treatment
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 |
|---|---|---|---|
| SFS 257-E-00 | None | None | None |