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| Sponsor: | 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 |
| 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 |
| 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 | |
| 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 | |
More Information
| 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 |
|
AIDS-Related Opportunistic Infections Dose-Response Relationship, Drug Fluconazole Antifungal Agents |
Candidiasis, Oral Drug Administration Schedule terbinafine |
|
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 |
