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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002394
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1999

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002394 on ClinicalTrials.gov Archive Site
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Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment
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.

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).

Interventional
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Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
  • Candidiasis, Oral
  • HIV Infections
Drug: Terbinafine hydrochloride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002394
282A, SFS 257-E-00
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Novartis
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NIH AIDS Clinical Trials Information Service
December 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP