Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: December 1999
History of Changes
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.
Drug : Terbinafine hydrochloride
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|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
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|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- Have liver or kidney disease.
- Have received certain medications.
- Have a history of serious diarrhea or digestive problems.
- Are pregnant or breast-feeding.
You will not be eligible for this study if you:
Contacts and LocationsChoosing 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 Show More
|United States, Florida|
|Therafirst Med Ctr|
|Fort Lauderdale, Florida, United States, 33308|
|Associates in Research|
|Fort Myers, Florida, United States, 33901|
|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 CollaboratorsNovartis
|ClinicalTrials.gov Identifier:||NCT00002394 History of Changes|
|Other Study ID Numbers:||282A|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:AIDS-Related Opportunistic Infections
Dose-Response Relationship, Drug
Drug Administration Schedule
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on October 19, 2017
This information is provided by ClinicalTrials.gov.