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

NCT ID: NCT00002394

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Candidiasis, Oral HIV Infections

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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Terbinafine hydrochloride

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Locations

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Therafirst Med Ctr

Fort Lauderdale, Florida, United States

Site Status

Associates in Research

Fort Myers, Florida, United States

Site Status

Clireco Inc

Tamarac, Florida, United States

Site Status

Infectious Diseases Research Inc

Tampa, Florida, United States

Site Status

Northwestern Univ / Division of Infectious Disease

Chicago, Illinois, United States

Site Status

Saint Michaels Med Ctr / Infectious Disease Resch Dpt

Newark, New Jersey, United States

Site Status

St Vincents Hosp / Clinical Research Program

New York, New York, United States

Site Status

Univ of Texas Med Branch

Galveston, Texas, United States

Site Status

Hampton Roads Med Specialists

Hampton, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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SFS 257-E-00

Identifier Type: -

Identifier Source: secondary_id

282A

Identifier Type: -

Identifier Source: org_study_id