Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002369
Status:
COMPLETED
Last Update Posted:
2007-10-02
First Post:
1999-11-02
Brief Title:
A Comparison of Epivir Plus Crixivan Combined With Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
An Open Label Randomized Comparative Study of Zerit d4T Epivir 3TC Crixivan Versus Retrovir AZT Epivir 3TC Crixivan in HIV-Infected Antiretroviral Naive Subjects With CD4 Cell Counts of 200 - 700 Cellsmm3 and HIV RNA Baseline Copy Number of 10000 Copiesml
Status:
COMPLETED
Status Verified Date:
2007-10
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 evaluate the tolerance and comparative virologic and immunologic effects of the two combination regimens
Detailed Description:
100 patients will be randomized to receive Zerit Stavudine Epivir Lamivudine Crixivan Indinavir and 100 patients will be randomized to receive Retrovir Zidovudine Epivir Lamivudine Crixivan Indinavir
Patients will be treated for 48 weeks
Patients will be treated 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 |
|---|---|---|---|
| BMS 001 | None | None | None |