Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment
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
2 other identifiers
interventional
30
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
December 1, 1999
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- You may be eligible for this study if you:
- Are at least 18 years old.
- Have thrush that has not responded to at least 10 days of fluconazole treatment.
- Are HIV-positive.
- Are expected to live at least 4 weeks.
- Are able to take oral medication.
You may not qualify if:
- You will not be eligible for this study if you:
- Have liver or kidney disease.
- Have received certain medications.
- Have a history of serious diarrhea or digestive problems.
- Are pregnant or breast-feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (9)
Therafirst Med Ctr
Fort Lauderdale, Florida, 33308, United States
Associates in Research
Fort Myers, Florida, 33901, United States
Clireco Inc
Tamarac, Florida, 33321, United States
Infectious Diseases Research Inc
Tampa, Florida, 33614, United States
Northwestern Univ / Division of Infectious Disease
Chicago, Illinois, 60611, United States
Saint Michaels Med Ctr / Infectious Disease Resch Dpt
Newark, New Jersey, 071029880, United States
St Vincents Hosp / Clinical Research Program
New York, New York, 10011, United States
Univ of Texas Med Branch
Galveston, Texas, 77555, United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1999-12