Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002224
Status:
COMPLETED
Last Update Posted:
2011-04-25
First Post:
1999-11-02
Brief Title:
Comparison of Two Anti-HIV Regimens That Include One of Two Forms of Didanosine ddI
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
Comparison of HIV RNA Suppression Produced by Triple Regimens Containing Either Didanosine Enteric Coated or Didanosine Formulations Each Administered Once Daily
Status:
COMPLETED
Status Verified Date:
2011-04
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:
Didanosine is an effective anti-HIV drug but it can cause stomach upset This study tests a new form of didanosine ddI EC a coated pill that passes through the stomach more easily and hopefully will prevent stomach upset The purpose of this study is to compare the effectiveness of ddI EC versus the standard form of ddI Both forms of ddI will be given with stavudine d4T plus nelfinavir NLF
Detailed Description:
Patients are randomized to 1 of 2 open-label treatment groups Group 1 receives ddI EC plus d4T plus NLF for 48 weeks Group 2 receives ddI plus d4T plus NLF for 48 weeks Both forms of ddI are administered orally once daily Antiviral activity is determined by the magnitude and the duration of reduction of plasma HIV RNA from baseline through Week 24
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 |
|---|---|---|---|
| AI454-158 | None | None | None |