Back to resultsA Study of the Side Effects of L-743,872 in Men With Candidal Esophagitis
Primary Purpose
Candidiasis, Esophageal, HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
L-743,872
Sponsored by
About this trial
This is an interventional treatment trial for Candidiasis, Esophageal focused on measuring Dose-Response Relationship, Drug, Antifungal Agents, Candidiasis, Esophageal Diseases, MK 0991
Eligibility Criteria
Inclusion Criteria You may be eligible for this study if you: Are an 18- to 65-year-old man with candidal esophagitis.
Sites / Locations
- Gary Calandra
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00005921
Brief Title
A Study of the Side Effects of L-743,872 in Men With Candidal Esophagitis
Official Title
An Open, Serial-Panel, Multiple-Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of L-743,872 in Patients With Candida Esophagitis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2000
Overall Recruitment Status
Completed
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 to give L-743,872 to men with candidal esophagitis, an AIDS-related yeast infection in the esophagus.
Detailed Description
In this open-label study, patients receive intravenous L-743,872 every 24 hours at one of three dose levels for 14 days. Post-study safety evaluations continue for 4 weeks after the final dose. Pharmacokinetics and safety measurements are taken throughout the 6-week study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis, Esophageal, HIV Infections
Keywords
Dose-Response Relationship, Drug, Antifungal Agents, Candidiasis, Esophageal Diseases, MK 0991
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)
Enrollment
18 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
L-743,872
10. Eligibility
Sex
Male
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:
Are an 18- to 65-year-old man with candidal esophagitis.
Facility Information:
Facility Name
Gary Calandra
City
Rahway
State/Province
New Jersey
ZIP/Postal Code
07065
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of the Side Effects of L-743,872 in Men With Candidal Esophagitis
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