NCT00002133

An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: Janssen, LP · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Candidiasis, Oral
• HIV Infections

Interventions

Type	Name	Description
DRUG	Itraconazole

Timeline

• First posted: 2001-08-31
• Last updated: 2005-06-24

Locations

18 sites across 1 country: United States