Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002371
Status:
COMPLETED
Last Update Posted:
2011-05-04
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken Zidovudine
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
A Randomized Double-Blind Study of Safety Virologic and Immunological Effects of Stavudine Plus Lamivudine 3TC Versus Zidovudine Plus Lamivudine in HIV-Infected Subjects Following At Least Six Months of Zidovudine 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:
To compare the magnitude and durability of the reduction in plasma HIV RNA in the two treatment groups over the first 12 weeks of treatment To determine the safety of each of the two treatment groups
Detailed Description:
Patients will be randomized to either Stavudine d4T Lamivudine 3TC Zidovudine placebo or Zidovudine ZDV Lamivudine Stavudine placebo Patients whose plasma HIV RNA levels remain 500 copiesml after 8 weeks of blinded double combination therapy will have indinavir added to their treatment regimen at the week 12 visit
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 |
|---|---|---|---|
| AI455-048 | None | None | None |