Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002313
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study of Nystatin in HIV-Infected Patients
Sponsor:
Argus Pharmaceuticals
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Extended Maintenance Protocol for Phase III Clinical Study of Nystatin IV Intravenous in Patients With HIV Infection NOTE Continuation Study Intended Only for Patients Who Have Completed FDA 103B
Status:
COMPLETED
Status Verified Date:
1994-04
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 evaluate the clinical toxicity safety and potential anti-HIV activity of intravenous nystatin in patients with HIV infection who have completed protocol FDA 103C To evaluate the safety and potential antiviral activity of intravenous nystatin and oral didanosine ddI administered in an alternating regimen in this patient population
Detailed Description:
Patients who have completed protocol FDA 103B are offered the option of receiving extended maintenance Patients who have received no prior ddI are treated either with intravenous nystatin alone at the same dose level administered in FDA 103B or with a regimen of intravenous nystatin and ddI alternating on 3-week cycles Treatment continues for 12 weeks
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 |
|---|---|---|---|
| AR-91-35606-005A | None | None | None |