Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005918
Status:
COMPLETED
Last Update Posted:
2011-05-04
First Post:
2000-06-15
Brief Title:
Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
The Safety and Antiviral Efficacy of Stavudine Extended Release Formulation as Compared to Stavudine Immediate Release Formulation Each as Part of Potent Antiretroviral Combination Therapy
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 compare the safety and effectiveness of 2 forms of stavudine d4T One form is taken once a day extended release and the other form is taken twice a day immediate release
Detailed Description:
Patients are randomized to receive blinded stavudine extended release d4T ER or immediate release d4T IR formulation Randomization is balanced by screening HIV viral load of less than 30000 copiesml or at least 30000 copiesml and by site Patients also receive open-label efavirenz EFV and lamivudine 3TC Efficacy is evaluated over 48 weeks of the dosing period and safety is evaluated over the entire dosing period 56 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 |
|---|---|---|---|
| AI455-099 | None | None | None |