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

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00002394

Collaborator

(none)

Enrollment

Locations

3.3

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Candidiasis, Oral HIV Infections	Drug: Terbinafine hydrochloride	N/A

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).

Study Design

Study Type:

Interventional

Intervention Model:

Parallel Assignment

Primary Purpose:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Therafirst Med Ctr	Fort Lauderdale	Florida	United States	33308
2	Associates in Research	Fort Myers	Florida	United States	33901
3	Clireco Inc	Tamarac	Florida	United States	33321
4	Infectious Diseases Research Inc	Tampa	Florida	United States	33614
5	Northwestern Univ / Division of Infectious Disease	Chicago	Illinois	United States	60611
6	Saint Michaels Med Ctr / Infectious Disease Resch Dpt	Newark	New Jersey	United States	071029880
7	St Vincents Hosp / Clinical Research Program	New York	New York	United States	10011
8	Univ of Texas Med Branch	Galveston	Texas	United States	77555
9	Hampton Roads Med Specialists	Hampton	Virginia	United States	23666