Safety and Effectiveness of Giving L-743,872 to Patients With Thrush That Has Not Been Cured With Fluconazole

This study has been terminated.

Sponsor:

Information provided by:

NIH AIDS Clinical Trials Information Service

ClinicalTrials.gov Identifier:

NCT00005920

First received: June 19, 2000

Last updated: June 23, 2005

Last verified: June 2000

History of Changes

Tracking Information
First Received Date ^ICMJE	June 19, 2000
Last Updated Date	June 23, 2005
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00005920 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Effectiveness of Giving L-743,872 to Patients With Thrush That Has Not Been Cured With Fluconazole
Official Title ^ICMJE	A Multiclinic, Double-Blind, Randomized, Dose-Comparison Study to Evaluate the Safety, Tolerability, and Efficacy of L-743,872 in the Treatment of Fluconazole-Unresponsive Oropharyngeal Candidiasis in Adults
Brief Summary	The purpose of this study is to see if it is safe and effective to give L-743,872 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-743,872 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 Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Primary Purpose: Treatment
Condition ^ICMJE	Candidiasis, Oral HIV Infections
Intervention ^ICMJE	Drug: L-743,872
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	70
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria You may be eligible for this study if you: Have thrush that has not responded to fluconazole treatment. Are 18-65 years old.
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00005920
Other Study ID Numbers ^ICMJE	267B, 012-00
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	June 2000
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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