Back to resultsSafety and Effectiveness of Giving L-743,872 to Patients With Thrush That Has Not Been Cured With Fluconazole
Primary Purpose
Candidiasis, Oral, HIV Infections
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
L-743,872
Sponsored by
About this trial
This is an interventional treatment trial for Candidiasis, Oral focused on measuring AIDS-Related Opportunistic Infections, Dose-Response Relationship, Drug, Fluconazole, Antifungal Agents, Candidiasis, Oral, Pharyngeal Diseases, MK 0991
Eligibility Criteria
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.
Sites / Locations
- Carol Sable
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00005920
Brief Title
Safety and Effectiveness of Giving L-743,872 to Patients With Thrush That Has Not Been Cured With Fluconazole
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2000
Overall Recruitment Status
Terminated
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis, Oral, HIV Infections
Keywords
AIDS-Related Opportunistic Infections, Dose-Response Relationship, Drug, Fluconazole, Antifungal Agents, Candidiasis, Oral, Pharyngeal Diseases, MK 0991
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Enrollment
70 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
L-743,872
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Carol Sable
City
Rahway
State/Province
New Jersey
ZIP/Postal Code
07065
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Effectiveness of Giving L-743,872 to Patients With Thrush That Has Not Been Cured With Fluconazole
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