Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Candidiasis, Oral; HIV Infections
Intervention: Terbinafine hydrochloride (Drug)
Phase: N/A
Status: Completed
Sponsored by: Novartis
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.
Clinical Details
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 design: Treatment, Parallel Assignment, Pharmacokinetics Study
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).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Therafirst Med Ctr, Fort Lauderdale, Florida 33308, United States
Associates in Research, Fort Myers, Florida 33901, United States
Infectious Diseases Research Inc, Tampa, Florida 33614, United States
Clireco Inc, Tamarac, Florida 33321, 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
Additional Information
Last updated: June 23, 2005
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