Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002447
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study to Compare Two Anti-HIV Drug Combinations
Sponsor:
Hoffmann-La Roche
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
An Open Label Randomized Multicenter Study to Evaluate Fortovase Saquinavir SGC QD Norvir Ritonavir QD Plus Two NRTIs Vs Sustiva Efavirenz QD Plus Two NRTIs in HIV Infected Patients
Status:
COMPLETED
Status Verified Date:
2001-01
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 compare 2 anti-HIV drug combinations
Detailed Description:
Patients are stratified by HIV RNA 5000-75000 vs greater than 75000 copiesml by Amplicor assay Patients are randomized to two arms Arm A receives SQV plus RTV plus two NRTIs Arm B receives EFV plus two NRTIs Patients must take their dose at approximately the same time every day Patients have the option of taking daily dose in AM or PM Patients are evaluated for changes in plasma HIV RNA levels and CD4CD8 counts and for adverse experiences and laboratory determinations Evaluations are made every 4-8 weeks until Week 48 Patients continuing beyond Week 48 who reach Weeks 60 72 84 and common study closure will be seen at those weeks
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 |
|---|---|---|---|
| NR15720CM61027 | None | None | None |