An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.
- Conditions
- Candidiasis, OralHIV Infections
- Registration Number
- NCT00002133
- Lead Sponsor
- Janssen, LP
- Brief Summary
To assess the efficacy and safety of itraconazole oral solution in HIV-seropositive patients with oropharyngeal candidiasis that is refractory to fluconazole.
- Detailed Description
Patients receive itraconazole oral solution twice daily. Per 08/15/94 amendment, patients with complete resolution of oropharyngeal candidiasis lesions upon completion of treatment are eligible for maintenance treatment on protocol FDA 236C. Patients who decline maintenance are followed for 6 weeks. Patients who relapse during follow-up are re-treated for 14-28 days; if lesions clear, patients may enter the maintenance protocol.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Univ of Arkansas for Med Sciences
🇺🇸Little Rock, Arkansas, United States
East Bay AIDS Ctr
🇺🇸Berkeley, California, United States
Kaiser Permanente Med Ctr
🇺🇸San Francisco, California, United States
Dr Douglas Ward
🇺🇸Washington, District of Columbia, United States
George Washington Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Veterans Administration Med Ctr
🇺🇸Washington, District of Columbia, United States
Infectious Diseases Research Clinic / Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Natl Inst of Allergy & Infect Dis / Cln Ctr
🇺🇸Bethesda, Maryland, United States
Ann Arbor Veterans Administration Med Ctr
🇺🇸Ann Arbor, Michigan, United States
Scroll for more (8 remaining)Univ of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States