Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment
Launched by NOVARTIS · Aug 30, 2001
Trial Information
Current as of May 18, 2025
Completed
Keywords
ClinConnect Summary
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 coho...
Gender
ALL
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.
About Novartis
Novartis is a global healthcare company based in Switzerland, dedicated to reimagining medicine to improve and extend people's lives. With a strong focus on innovative pharmaceuticals, Novartis engages in the research, development, and commercialization of a wide range of therapies across various therapeutic areas, including oncology, cardiology, immunology, and neuroscience. The company is committed to advancing clinical research through rigorous trials that prioritize patient safety and efficacy, aiming to deliver groundbreaking treatments and solutions that address unmet medical needs worldwide. Novartis's commitment to innovation and collaboration positions it at the forefront of the biopharmaceutical industry, driving advancements that enhance patient care and health outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Galveston, Texas, United States
Hampton, Virginia, United States
Fort Lauderdale, Florida, United States
Fort Myers, Florida, United States
Tamarac, Florida, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Newark, New Jersey, United States
New York, New York, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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