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Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment Clinical research trials and Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment. Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment clinical trial. Subjects typically recieve the finest healthcare available for their Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment  Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment
Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment
For Condition: Candidiasis, Oral,HIV Infections
Status: Completed
Sponsor(s): Novartis Pharmaceuticals ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Parallel Assignment, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 30
Location and Contact Information:
Clireco Inc
Tamarac, Florida, 33321
United States
Therafirst Med Ctr
Ft. Lauderdale, Florida, 33308
United States
St Vincents Hosp / Clinical Research Program
New York City, New York, 10011
United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666
United States
Infectious Diseases Research Inc
Tampa, Florida, 33614
United States
Saint Michaels Med Ctr / Infectious Disease Resch Dpt
Newark, New Jersey, 071029880
United States
Northwestern Univ / Division of Infectious Disease
Chicago, Illinois, 60611
United States
Univ of Texas Med Branch
Galveston, Texas, 77555
United States
Associates in Research
Ft. Myers, Florida, 33901
United States
Additional Information:
Study ID Numbers: 282A; SFS 257-E-00
Study Start Date:
Record last reviewed: December 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002394
Other Hiv Infections Studies:
1. Emtricitabine Given Once A Day with Other Anti-HIV Drugs in Children with HIV
2. Treatment of Hepatitis in Patients who are Triple-Infected with HIV, Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV)
3. Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites
4. Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection
5. Discontinuation of Antiretroviral Therapy in Patients With Asymptomatic HIV Infection
Related Studies:
Other HIV Infections Clinical Trials
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Other Chicago Clinical Trials
Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment
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