Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000803
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Phase II Double-Blind Study of Delavirdine Mesylate U-90152 in Combination With Zidovudine AZT andor Didanosine ddI Versus AZT and ddI Combination Therapy
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 Double-Blind Study of Delavirdine Mesylate U-90152 in Combination With Zidovudine AZT andor Didanosine ddI Versus AZT and ddI Combination Therapy
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 determine the safety and anti-HIV activity of delavirdine mesylate U-90152 in combination with zidovudine AZT andor didanosine ddI versus AZTddI combination
U-90152 has demonstrated anti-HIV activity Since the combination of this drug with either AZT or ddI has synergistic inhibitory activity against HIV-1 in vitro and triple therapy appears to have greater inhibitory activity against HIV-1 in vitro than dual therapy the use of U-90152 in combination with AZT andor ddI may improve the benefits of these drugs in persons with HIV disease
U-90152 has demonstrated anti-HIV activity Since the combination of this drug with either AZT or ddI has synergistic inhibitory activity against HIV-1 in vitro and triple therapy appears to have greater inhibitory activity against HIV-1 in vitro than dual therapy the use of U-90152 in combination with AZT andor ddI may improve the benefits of these drugs in persons with HIV disease
Detailed Description:
U-90152 has demonstrated anti-HIV activity Since the combination of this drug with either AZT or ddI has synergistic inhibitory activity against HIV-1 in vitro and triple therapy appears to have greater inhibitory activity against HIV-1 in vitro than dual therapy the use of U-90152 in combination with AZT andor ddI may improve the benefits of these drugs in persons with HIV disease
Patients are randomized to receive U-90152AZTddI U-90152AZT U-90152ddI or AZTddI for 48 weeks
Patients are randomized to receive U-90152AZTddI U-90152AZT U-90152ddI or AZTddI for 48 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 |
|---|---|---|---|
| 11238 | REGISTRY | DAIDS-ES Registry Number | None |