Status:
COMPLETED
A Study To Assess GW433908 (Fosamprenavir) Containing Regimens In HIV-1 Infected Subjects
Lead Sponsor:
ViiV Healthcare
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Infection, Human Immunodeficiency Virus
Eligibility:
All Genders
13+ years
Phase:
PHASE3
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 150m...
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.
Eligibility Criteria
Inclusion
- Male or non-pregnant/non-lactating females \>/=13 years of age (or \>/= 18 years of age according to local requirements).
- Received fosamprenavir through prior participation in APV20001, APV30002, APV30003 or PRO30017 or have participated in APV30001 or other studies as deemed appropriate by the project team.
Exclusion
- Permanent discontinuation of GW433908 in a previous study due to intolerance.
- An active CDC Class C Event.
- Any condition which, in the opinion of the investigator, would preclude a subject from participation.
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
753 Patients enrolled
Trial Details
Trial ID
NCT00296504
Start Date
November 1 2001
End Date
October 1 2010
Last Update
April 19 2013
Active Locations (24)
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1
GSK Investigational Site
Fountain Valley, California, United States, 92708
2
GSK Investigational Site
San Francisco, California, United States, 94115-1931
3
GSK Investigational Site
Denver, Colorado, United States, 80262
4
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33145