Observational Study Of A Protease Inhibitor (PI) Containing Regimen In Subjects With PI Mutations Selected During Prior Treatment With GW433908 (Fosamprenavir)
A 24 Week Phase IIIb/IV Single Arm Open Label Observational Study to Explore the Efficacy of Protease Inhibitors Given in Combination With Reverse Transcriptase Inhibitors to HIV-1 Infected Subjects With Protease Mutations Selected During Therapy With GW433908 Containing Antiretroviral Therapy
1 other identifier
interventional
20
2 countries
7
Brief Summary
This study will assess the efficacy of subsequent protease inhibitor (PI)-containing therapy in subjects who have acquired HIV-1 protease mutations whilst receiving a GW433908 (fosamprenavir)-containing regimen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2003
Typical duration for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 19, 2005
CompletedFirst Posted
Study publicly available on registry
October 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedMay 30, 2017
May 1, 2017
2.6 years
October 19, 2005
May 25, 2017
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Prior participation in study APV30005 AND one of the following studies: APV30001, APV30002, AZL30006, APV30003.
- Must be failing virologically (\>1000 copies at two consecutive time-points) and have a screening genotype with evidence of at least one new APV-associated protease mutation: V32I (+/- I47V), I50V, I54L/M, I84V acquired since commencing treatment with GW433908.
You may not qualify if:
- Have 2 or more of the primary resistance mutations D30N, G48V, V82A/F/T/S and L90M.
- Have a medical need for use of an non-nucleoside reductase transferase inhibitor (NNRTI).
- Have an acute CDC Class C event requiring therapeutic intervention.
- Are pregnant or lactating.
- Have any other condition which in the opinion of the investigator would preclude their participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ViiV Healthcarelead
Study Sites (7)
GSK Investigational Site
Fort Lauderdale, Florida, 33308, United States
GSK Investigational Site
Orlando, Florida, 32804, United States
GSK Investigational Site
Tampa, Florida, 33614, United States
GSK Investigational Site
Atlanta, Georgia, 30308/30309, United States
GSK Investigational Site
Atlanta, Georgia, 30308, United States
GSK Investigational Site
Augusta, Georgia, 30912, United States
GSK Investigational Site
Brescia, Lombardy, 25125, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials, MD
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2005
First Posted
October 21, 2005
Study Start
June 1, 2003
Primary Completion
January 1, 2006
Study Completion
January 1, 2006
Last Updated
May 30, 2017
Record last verified: 2017-05