Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002240
Status:
COMPLETED
Last Update Posted:
2011-05-04
First Post:
1999-11-02
Brief Title:
Study of a New Protease Inhibitor BMS-232632 in Combination With Other Anti-HIV Drugs
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
Evaluation of the Safety and Antiviral Efficacy of a Novel HIV-1 Protease Inhibitor BMS-232632 Alone and in Combination With d4T and ddI as Compared to a Reference Combination Regimen
Status:
COMPLETED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate a new protease inhibitor known as BMS-232632 This drug will be given in combination with 2 other anti-HIV drugs stavudine and didanosine The effectiveness of BMS-232632 against HIV infection will be compared to that of nelfinavir a protease inhibitor that is already commonly prescribed
Detailed Description:
Patients are randomized to receive one of two drug regimens BMS-232632 ddI and d4T or NFV ddI and d4T Three different doses of BMS-232632 are used in this study Randomization is stratified for HIV RNA level less than 30000 copiesml versus 30000 or greater copiesml Patients remain on their drug regimen for 48 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AI424-007 | None | None | None |