Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005920
Status:
TERMINATED
Last Update Posted:
2005-06-24
First Post:
2000-06-19
Brief Title:
Safety and Effectiveness of Giving L-743872 to Patients With Thrush That Has Not Been Cured With Fluconazole
Sponsor:
Merck Sharp Dohme LLC
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Multiclinic Double-Blind Randomized Dose-Comparison Study to Evaluate the Safety Tolerability and Efficacy of L-743872 in the Treatment of Fluconazole-Unresponsive Oropharyngeal Candidiasis in Adults
Status:
TERMINATED
Status Verified Date:
2000-06
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 L-743872 to patients with thrush an AIDS-related yeast infection of the mouth that has not been cured with fluconazole treatment
Detailed Description:
Patients are randomized to treatment with L-743872 at one of two doses administered intravenously by a peripheral line once-daily Patients are treated for 48 hours beyond resolution of symptoms or for a maximum of 14 days Each patient is expected to complete the study including the 14-day follow-up within approximately 4 weeks A physical examination is performed daily during the antifungal treatment period and at the follow-up visits 7 and 14 days post-therapy Laboratory tests of blood and urine for safety are performed every three days during treatment and at follow-up 7 days post-therapy Liver enzymes are drawn at the 14-day follow-up visit
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 |
|---|---|---|---|
| 012-00 | None | None | None |