Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001065
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Brief Title:
A Study of Amphotericin B in the Treatment of Fungal Infections of the Mouth in HIV-Infected Patients Who Have Not Had Success With Fluconazole
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Trial of Amphotericin B Oral Suspension for Fluconazole-Resistant Oral Candidiasis in HIV-Infected Patients
Status:
COMPLETED
Status Verified Date:
2021-10
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 response and toxicity in patients with fluconazole-resistant oral candidiasis thrush when given initial induction with amphotericin B oral suspension
Experience with amphotericin B oral suspension for drug-sensitive thrush in HIV-infected patients is limited but encouraging
Experience with amphotericin B oral suspension for drug-sensitive thrush in HIV-infected patients is limited but encouraging
Detailed Description:
Experience with amphotericin B oral suspension for drug-sensitive thrush in HIV-infected patients is limited but encouraging
Patients swish and swallow amphotericin B oral suspension after each meal and at bedtime for 14 days at which time they are deemed a responder nonresponder or failure to induction therapy Responders receive maintenance twice daily while nonresponders receive 14 further days of initial induction Failures discontinue the study Responders after 28 days of induction are placed on maintenance After successful completion of initial induction patients remain on study for 6 months
Patients swish and swallow amphotericin B oral suspension after each meal and at bedtime for 14 days at which time they are deemed a responder nonresponder or failure to induction therapy Responders receive maintenance twice daily while nonresponders receive 14 further days of initial induction Failures discontinue the study Responders after 28 days of induction are placed on maintenance After successful completion of initial induction patients remain on study for 6 months
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 |
|---|---|---|---|
| 11271 | REGISTRY | DAIDS ES Registry Number | None |