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
  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

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Novartis
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002394     History of Changes
Other Study ID Numbers: 282A, SFS 257-E-00
Study First Received: November 2, 1999
Last Updated: June 23, 2005
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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Candidiasis
Candidiasis, Oral
HIV Seropositivity
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Mycoses
Mouth Diseases
Stomatognathic Diseases
Fluconazole
Terbinafine
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014