Clinical trial NCT00002394: Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Candidiasis, Oral
HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Dose-Response Relationship, Drug
Fluconazole
Antifungal Agents
Candidiasis, Oral
Drug Administration Schedule
terbinafine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Therafirst Med Ctr
state: Florida
city: Fort Myers
country: United States
facility: Associates in Research
state: Florida
city: Tamarac
country: United States
facility: Clireco Inc
state: Florida
city: Tampa
country: United States
facility: Infectious Diseases Research Inc
state: Florida
city: Chicago
country: United States
facility: Northwestern Univ / Division of Infectious Disease
state: Illinois
city: Newark
country: United States
facility: Saint Michaels Med Ctr / Infectious Disease Resch Dpt
state: New Jersey
city: New York
country: United States
facility: St Vincents Hosp / Clinical Research Program
state: New York
city: Galveston
country: United States
facility: Univ of Texas Med Branch
state: Texas
city: Hampton
country: United States
facility: Hampton Roads Med Specialists
state: Virginia
Study officials:
References: