Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment
- Conditions
- Candidiasis, OralHIV Infections
- Registration Number
- NCT00002394
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
This is an open-label, dose-escalating study with up to 2 sequential cohorts. The first 15 patients receive Lamisil for 2 weeks. After 2 weeks, patients considered clinically cured (i.e., absence of removable, white plaques) are removed from treatment; patients not considered clinically cured receive an additional 2 weeks of treatment. At the end of 4 weeks, treatment is discontinued, regardless of clinical cure outcome. If less than 80% of patients are clinically cured after the 4 weeks of treatment, a second cohort of 15 patients receive Lamisil on the same treatment regimen as first cohort (i.e., initial 2-week treatment period, with an additional 2 weeks of treatment for those patients who are not considered clinically cured after 2 weeks of treatment).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Univ of Texas Med Branch
🇺🇸Galveston, Texas, United States
Hampton Roads Med Specialists
🇺🇸Hampton, Virginia, United States
Therafirst Med Ctr
🇺🇸Fort Lauderdale, Florida, United States
Associates in Research
🇺🇸Fort Myers, Florida, United States
Saint Michaels Med Ctr / Infectious Disease Resch Dpt
🇺🇸Newark, New Jersey, United States
Infectious Diseases Research Inc
🇺🇸Tampa, Florida, United States
Northwestern Univ / Division of Infectious Disease
🇺🇸Chicago, Illinois, United States
Clireco Inc
🇺🇸Tamarac, Florida, United States
St Vincents Hosp / Clinical Research Program
🇺🇸New York, New York, United States