Candidiasis, Oral, HIV Infections
Conditions
Keywords
AIDS-Related Opportunistic Infections, Dose-Response Relationship, Drug, Fluconazole, Antifungal Agents, Candidiasis, Oral, Drug Administration Schedule, terbinafine
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).
Interventions
Sponsors
Novartis
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed