Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002133
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects
Sponsor:
Janssen LP
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects
Status:
COMPLETED
Status Verified Date:
1996-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 081594 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ITR-USA-94 | None | None | None |