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	Treatment or Intervention
Candidiasis, Oral HIV Infections	Drug: Terbinafine hydrochloride

Further Study Details: 

Expected Total Enrollment:  30

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).

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  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.

Florida
      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
Illinois
      Northwestern Univ / Division of Infectious Disease, Chicago,  Illinois,  60611,  United States
New Jersey
      Saint Michaels Med Ctr / Infectious Disease Resch Dpt, Newark,  New Jersey,  071029880,  United States
New York
      St Vincents Hosp / Clinical Research Program, New York,  New York,  10011,  United States
Texas
      Univ of Texas Med Branch, Galveston,  Texas,  77555,  United States
Virginia
      Hampton Roads Med Specialists, Hampton,  Virginia,  23666,  United States

Study ID Numbers:  282A; SFS 257-E-00
Record last reviewed:  December 1999
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002394
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08