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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 Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. 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 website committed 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 happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds 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 permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes 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. Participants frequently obtain the most expert healthcare available for their Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict 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. Comparing Side Effects of Two Forms of Videx in HIV-Infected Adults
2. Phase I Trial of S-1153 in Patients With HIV Infection
3. A Study of Patients Who Recently Have Been Infected with HIV
4. A Study of LIPO-5 and ALVAC-HIV (vCP1452) as Possible HIV Vaccines
5. A Study of MKC-442 in HIV-Positive Patients
Related Studies:
Other HIV Infections Clinical Trials
Other Florida Clinical Trials
Other Ft. Lauderdale 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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