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Safety and Effectiveness of Giving L-743,872 to Patients with Thrush That Has Not Been Cured With Fluconazole



Safety and Effectiveness of Giving L-743,872 to Patients with Thrush That Has Not Been Cured With Fluconazole

For Condition: Candidiasis, Oral,HIV Infections
Status: Terminated
Sponsor(s): Merck Research Laboratories ,
Synopsis: The purpose of this study is to see if it is safe and effective to give L-743,872 to patients with thrush, an AIDS-related yeast infection of the mouth, that has not been cured with fluconazole treatment.
Details: Patients are randomized to treatment with L-743,872 at one of two doses administered intravenously by a peripheral line once-daily. Patients are treated for 48 hours beyond resolution of symptoms or for a maximum of 14 days. Each patient is expected to complete the study, including the 14-day follow-up, within approximately 4 weeks. A physical examination is performed daily during the antifungal treatment period and at the follow-up visits 7 and 14 days post-therapy. Laboratory tests of blood and urine for safety are performed every three days during treatment and at follow-up 7 days post-therapy. Liver enzymes are drawn at the 14-day follow-up visit.
Eligibility:
Study Type:
  Interventional, Treatment, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria You may be eligible for this study if you: - Have thrush that has not responded to fluconazole treatment. - Are 18-65 years old.
Total Enrollment: 70

Location and Contact Information:

Carol Sable
Rahway,  New Jersey,  07065
United States
 


Additional Information:
Study ID Numbers:
  267B;  012-00
Study Start Date: 
Record last reviewed: June 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005920

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