Back to resultsSafety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment
Primary Purpose
Candidiasis, Oral, HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Terbinafine hydrochloride
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, Drug Administration Schedule, terbinafine
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria 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.
Sites / Locations
- Therafirst Med Ctr
- Associates in Research
- Clireco Inc
- Infectious Diseases Research Inc
- Northwestern Univ / Division of Infectious Disease
- Saint Michaels Med Ctr / Infectious Disease Resch Dpt
- St Vincents Hosp / Clinical Research Program
- Univ of Texas Med Branch
- Hampton Roads Med Specialists
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002394
Brief Title
Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 1999
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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).
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, Drug Administration Schedule, terbinafine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Terbinafine hydrochloride
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
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.
Facility Information:
Facility Name
Therafirst Med Ctr
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Associates in Research
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Clireco Inc
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Infectious Diseases Research Inc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Northwestern Univ / Division of Infectious Disease
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Saint Michaels Med Ctr / Infectious Disease Resch Dpt
City
Newark
State/Province
New Jersey
ZIP/Postal Code
071029880
Country
United States
Facility Name
St Vincents Hosp / Clinical Research Program
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Univ of Texas Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Hampton Roads Med Specialists
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment
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