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| 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 |
| 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 |
| Estimated Enrollment: | 30 |
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 |
Inclusion Criteria
You may be eligible for this study if you:
Exclusion Criteria
You will not be eligible for this study if you:
Contacts and 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 | |||||
| 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 |
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