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”

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.

Study Type: Interventional

Study Design: Treatment, Parallel Assignment, Pharmacokinetics Study

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).

Intervention(s) in this Clinical Trial

• Drug: Terbinafine hydrochloride

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002394

Study ID Number: 282A

ClinicalTrials.gov Identifier: NCT00002394

Health Authority: United States: Food and Drug Administration