Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002178
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Phase IIIB Open-Label Comparative Study to Evaluate Saquinavir Soft Gel Capsule SGC Treatment in Combination With Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients
Sponsor:
Hoffmann-La Roche
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase IIIB Open-Label Comparative Study to Evaluate Saquinavir Soft Gel Capsule SGC Treatment in Combination With Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients
Status:
COMPLETED
Status Verified Date:
1997-08
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:
To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection 400 copiesml at week 16 and 24 of study therapy To determine the absolute change in plasma HIV-1 RNA and in absolute CD4 cell count during the 24 weeks of study treatment To collect safety data on the treatment regimens To determine the percentage of patients without SQV soft gel capsules resistance-associated mutations at week 24
Detailed Description:
Patients are randomized to receive 1 of 3 study regimens Group A - Saquinavir SQV soft gel capsules sgc plus 2 reverse transcriptase inhibitors RTIs Group B - SQV sgc plus delavirdine plus RTI and Group C - SQV sgc plus nelfinavir plus RTI or SQV sgc plus ritonavir plus 2 RTIs
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 |
|---|---|---|---|
| NR15539 | None | None | None |