Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2026-02-12 @ 5:54 PM
Study NCT ID:
NCT00296504
Status:
COMPLETED
Last Update Posted:
2013-04-19
First Post:
2006-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study To Assess GW433908 (Fosamprenavir) Containing Regimens In HIV-1 Infected Subjects
Sponsor:
ViiV Healthcare
Organization:
Study Overview
Official Title:
An Open-Label Phase III Study to Assess the Long Term Safety Profile of GW433908 Containing Regimens in HIV-1 Infected Subjects
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
GW433908 (fosamprenavir; FPV)is a pro-drug of amprenavir (APV) which is more water soluble and can be formulated into a tablet with a reduced pill burden (four 700mg tablets of FPV versus sixteen 150mg capsules daily for APV. This study is designed to provide additional information on long term safety and tolerability of FPV containing regimens for those subjects who received FPV in previous GlaxoSmithKline studies.
Detailed Description:
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.
Study Oversight
Has Oversight DMC:
False
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?: