Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002229
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Safety and Effectiveness of Adding Saquinavir FORTOVASE in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients
Sponsor:
Hoffmann-La Roche
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase IV Non-Comparative Study to Evaluate FORTOVASE Saquinavir Soft Gel Capsule SGC TID Regimen in Combination With Two NRTIs in HIV-1 Infected Women and Men
Status:
COMPLETED
Status Verified Date:
1999-12
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:
The purpose of this study is to see if it is safe and effective to give saquinavir as a soft gel capsule taken by mouth along with 2 other anti-HIV drugs to HIV-infected patients
Detailed Description:
Prior to initiation of study treatment all patients are screened and baseline lab values are taken Patients then receive the study treatment FORTOVASE two times a day plus 2 new NRTIs Assessments will be performed at specified intervals throughout the duration of treatment
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 |
|---|---|---|---|
| NR15750 | None | None | None |