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

This study has been completed.

Sponsored by: Novartis
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002394
  Purpose

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 Intervention
Candidiasis, Oral
HIV Infections
Drug: Terbinafine hydrochloride

MedlinePlus related topics:   AIDS    Yeast Infections   

Drug Information available for:   Clotrimazole    Miconazole    Miconazole nitrate    Tioconazole    Fluconazole    Terbinafine    Terbinafine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Parallel Assignment, Pharmacokinetics Study
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

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:   30

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).

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002394

Locations
United States, Florida
Therafirst Med Ctr    
      Fort Lauderdale, Florida, United States, 33308
Associates in Research    
      Fort Myers, Florida, United States, 33901
Infectious Diseases Research Inc    
      Tampa, Florida, United States, 33614
Clireco Inc    
      Tamarac, Florida, United States, 33321
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
Novartis
  More Information


Study ID Numbers:   282A, SFS 257-E-00
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002394
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections  
Dose-Response Relationship, Drug  
Fluconazole  
Antifungal Agents  
Candidiasis, Oral
Drug Administration Schedule
terbinafine

Study placed in the following topic categories:
Fluconazole
Mouth Diseases
Opportunistic Infections
Candidiasis, Oral
Sexually Transmitted Diseases, Viral
Candidiasis
Clotrimazole
Miconazole
Acquired Immunodeficiency Syndrome
Tioconazole
Immunologic Deficiency Syndromes
Virus Diseases
Mycoses
Signs and Symptoms
HIV Seropositivity
HIV Infections
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
Stomatognathic Diseases
Retroviridae Infections
Terbinafine

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Therapeutic Uses
Antifungal Agents
Lentivirus Infections
Enzyme Inhibitors
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




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