Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002394
• Other study ID #: 282A
• Secondary ID: SFS 257-E-00
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: December 1999
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Oral
• HIV Infections

Intervention

Drug:
• Terbinafine hydrochloride

Locations

Country	Name	City	State
United States	Northwestern Univ / Division of Infectious Disease	Chicago	Illinois
United States	Therafirst Med Ctr	Fort Lauderdale	Florida
United States	Associates in Research	Fort Myers	Florida
United States	Univ of Texas Med Branch	Galveston	Texas
United States	Hampton Roads Med Specialists	Hampton	Virginia
United States	St Vincents Hosp / Clinical Research Program	New York	New York
United States	Saint Michaels Med Ctr / Infectious Disease Resch Dpt	Newark	New Jersey
United States	Clireco Inc	Tamarac	Florida
United States	Infectious Diseases Research Inc	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States,