Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004583
Status:
COMPLETED
Last Update Posted:
2009-02-20
First Post:
1999-11-02
Brief Title:
A Phase III Study Comparing Two Different Anti-HIV Drug Combinations in HIV-Positive Patients Without Previous Anti-HIV Drug Therapy
Sponsor:
Abbott
Organization:
Abbott
Study Overview
Official Title:
A Randomized Double-Blind Phase III Study of ABT-378Ritonavir Plus Stavudine and Lamivudine vs Nelfinavir Plus Stavudine and Lamivudine in Antiretroviral Naive HIV-Infected Subjects
Status:
COMPLETED
Status Verified Date:
2009-02
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:
The purpose of this study is to see how safe a new protease inhibitor PI is and how well it fights HIV infection A PI is a drug that stops HIV from using healthy cells to make more virus This study will compare the new PI combination of ABT-378 plus ritonavir RTV with another PI nelfinavir NFV
Earlier studies suggest ABT-378RTV will be just as good as and perhaps better than NFV at fighting HIV infection
Earlier studies suggest ABT-378RTV will be just as good as and perhaps better than NFV at fighting HIV infection
Detailed Description:
Based on the accumulated studies to date it is expected that ABT-378ritonavir will provide efficacy that is at least as good as or superior to nelfinavir when used in combination with reverse transcriptase inhibitors
Patients are equally randomized to one of two treatment arms In one arm approximately 330 patients receive ABT-378ritonavir plus nelfinavir placebo In the other arm approximately 330 patients receive nelfinavir plus ABT-378ritonavir placebo In both arms these protease inhibitors are blinded to the investigator patient and sponsor Both arms receive open-label stavudine and lamivudine Vital sign measurements physical examinations ECGs routine clinical laboratory evaluations and determinations of antiviral and immunologic activity are performed at intervals throughout the study
Patients are equally randomized to one of two treatment arms In one arm approximately 330 patients receive ABT-378ritonavir plus nelfinavir placebo In the other arm approximately 330 patients receive nelfinavir plus ABT-378ritonavir placebo In both arms these protease inhibitors are blinded to the investigator patient and sponsor Both arms receive open-label stavudine and lamivudine Vital sign measurements physical examinations ECGs routine clinical laboratory evaluations and determinations of antiviral and immunologic activity are performed at intervals throughout the study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| M98-863 | None | None | None |