Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00094523
Status:
COMPLETED
Last Update Posted:
2018-04-18
First Post:
2004-10-20
Brief Title:
Fosamprenavir Versus Other Protease Inhibitors
Sponsor:
ViiV Healthcare
Organization:
ViiV Healthcare
Study Overview
Official Title:
A Phase IIIBIV Open-label Multi-center Trial to Evaluate the Safety Tolerability and Efficiency of HIV-1 Infected Subjects Switching Their Current Protease-inhibitor Therapies for a Fosamprenavir Therapy Over 48 Weeks
Status:
COMPLETED
Status Verified Date:
2018-04
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:
This study was designed to evaluate and compare safety tolerability of subjects who successfully suppress HIV-1 on their first PI regimen to those who switch to fosamprenavir This is a 48-week study where subjects who were assigned to be in their original PI-group have the option of switching to fosamprenavir on week 24 Prior to being assigned their treatment group subjects had to be suppressed for at least three months All subjects also take a background regimen of two nucleosidenucleotide reverse transcriptase inhibitors
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None