Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001040
Status:
COMPLETED
Last Update Posted:
2011-03-01
First Post:
1999-11-02
Brief Title:
Comparison of Ro 31-8959 Plus Zidovudine AZT Versus AZT Plus Zalcitabine ddC Versus Ro 31-8959 Plus AZT Plus ddC
Sponsor:
Hoffmann-La Roche
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Double-Blind Randomized Phase II Study of Ro 31-8959 Plus Zidovudine AZT Versus AZT Plus Zalcitabine Dideoxycytidine ddC Versus Ro 31-8959 Plus AZT Plus ddC
Status:
COMPLETED
Status Verified Date:
2011-02
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 determine the efficacy and toxicity of three treatment regimens saquinavir mesylate Ro 31-8959 plus zidovudine AZT vs AZT plus zalcitabine dideoxycytidine ddC vs Ro 31-8959 plus AZT plus ddC
SECONDARY To investigate the pharmacokinetics and effects on various clinical parameters of the three regimens
SECONDARY To investigate the pharmacokinetics and effects on various clinical parameters of the three regimens
Detailed Description:
None
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 |
|---|---|---|---|
| FDA 123A | None | None | None |
| NV14255D | None | None | None |