Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000810
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
Randomized Phase III Dose-Ranging Open-Label Trial of the Anti-HIV Activity of Delavirdine Mesylate DLV U-90152S
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Randomized Phase III Dose-Ranging Open-Label Trial of the Anti-HIV Activity of Delavirdine Mesylate DLV U-90152S
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:
PRIMARY To study the safety and tolerance of delavirdine mesylate U-90152 monotherapy To compare the anti-HIV activity of three blood concentration levels of this agent with nucleoside analog monotherapy either zidovudine AZT or didanosine ddI based on the reduction of HIV viral burden
SECONDARY To use pharmacokinetic parameters to assess the relationship between daily drug exposure and antiviral activity and toxicity of the U-90152 AZT and ddI monotherapy To assess anti-HIV activity using other disease markers
Data suggest that bisheteroarylpiperazines BHAPs such as delavirdine mesylate are potent and safe anti-HIV agents and may have different biological behavior than other currently available non-nucleoside RT inhibitors
SECONDARY To use pharmacokinetic parameters to assess the relationship between daily drug exposure and antiviral activity and toxicity of the U-90152 AZT and ddI monotherapy To assess anti-HIV activity using other disease markers
Data suggest that bisheteroarylpiperazines BHAPs such as delavirdine mesylate are potent and safe anti-HIV agents and may have different biological behavior than other currently available non-nucleoside RT inhibitors
Detailed Description:
Data suggest that bisheteroarylpiperazines BHAPs such as delavirdine mesylate are potent and safe anti-HIV agents and may have different biological behavior than other currently available non-nucleoside RT inhibitors
Patients are randomized to receive U-90152 at one of three doses treatment arms I through III or either AZT or ddI treatment arm IV Patients on arm IV who are AZT-naive receive AZT those who are AZT-experienced receive ddI Treatment continues for 24 weeks
PER 122294 AMENDMENT All patients receiving U-90152 have the same starting dose to attain one of three target trough levels
Patients are randomized to receive U-90152 at one of three doses treatment arms I through III or either AZT or ddI treatment arm IV Patients on arm IV who are AZT-naive receive AZT those who are AZT-experienced receive ddI Treatment continues for 24 weeks
PER 122294 AMENDMENT All patients receiving U-90152 have the same starting dose to attain one of three target trough levels
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 |
|---|---|---|---|
| 11237 | REGISTRY | DAIDS-ES | None |