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

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ClinicalTrials.gov Identifier: NCT00002394
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

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 Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002394

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United States, Florida
Therafirst Med Ctr
Fort Lauderdale, Florida, United States, 33308
Associates in Research
Fort Myers, Florida, United States, 33901
Clireco Inc
Tamarac, Florida, United States, 33321
Infectious Diseases Research Inc
Tampa, Florida, United States, 33614
United States, Illinois
Northwestern Univ / Division of Infectious Disease
Chicago, Illinois, United States, 60611
United States, New Jersey
Saint Michaels Med Ctr / Infectious Disease Resch Dpt
Newark, New Jersey, United States, 071029880
United States, New York
St Vincents Hosp / Clinical Research Program
New York, New York, United States, 10011
United States, Texas
Univ of Texas Med Branch
Galveston, Texas, United States, 77555
United States, Virginia
Hampton Roads Med Specialists
Hampton, Virginia, United States, 23666
Sponsors and Collaborators
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ClinicalTrials.gov Identifier: NCT00002394    
Other Study ID Numbers: 282A
SFS 257-E-00
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 1999
Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections
Dose-Response Relationship, Drug
Antifungal Agents
Candidiasis, Oral
Drug Administration Schedule
Additional relevant MeSH terms:
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Candidiasis, Oral
Bacterial Infections and Mycoses
Mouth Diseases
Stomatognathic Diseases
Antifungal Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action