Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002425
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs
Sponsor:
Hoffmann-La Roche
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Multicenter Open-Label Study of the Safety and Activity of Saquinavir Soft Gelatin Capsule Formulation Saquinavir SGC in Combination With Other Antiretroviral Drugs
Status:
COMPLETED
Status Verified Date:
1996-12
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 evaluate the safety and antiretroviral activity of saquinavir soft gelatin capsule formulation SQV-SGC in combination with other antiretroviral drugs
Detailed Description:
All patients receive SQV as monotherapy or in combination with other antiretroviral drugs chosen by the investigator and patient This study provides only SQV Patients may not choose another protease inhibitor PI as part of their combination therapy furthermore patients taking PIs other than SQV must undergo a 5-day washout period before study-drug administration Patients are monitored for adverse events and changes in routine laboratory tests plasma viral load and CD4 T cell levels Outcomes are analyzed by stratifying patients according to CD4 T cell levels and prior history with protease inhibitors
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 |
|---|---|---|---|
| NV15182B | None | None | None |