Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002429
Status:
COMPLETED
Last Update Posted:
2011-05-04
First Post:
1999-11-02
Brief Title:
Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine ddI EC Compared to a Typical Anti-HIV Drug Regimen
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
Evaluation of HIV RNA Suppression Produced by a Triple Combination Regimen Containing an Enteric Coated Formulation of Didanosine ddI EC Administered Once Daily 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:
This study tests a new form of didanosine ddI EC a coated pill that passes through the stomach before dissolving The purpose of this study is to compare the effectiveness of an anti-HIV drug combination that includes ddI EC versus another anti-HIV drug combination
Detailed Description:
Patients are randomized to 1 of 2 groups for 48 weeks of open-label treatment Group 1 receives ddI EC plus d4T plus NFV Group 2 receives Combivir plus NFV Antiviral activity is determined by the proportion of patients with HIV RNA levels of less than 400 copiesml at Week 48
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 |
|---|---|---|---|
| AI454-152 | None | None | None |