Status:
COMPLETED
Observational Study Of A Protease Inhibitor (PI) Containing Regimen In Subjects With PI Mutations Selected During Prior Treatment With GW433908 (Fosamprenavir)
Lead Sponsor:
ViiV Healthcare
Conditions:
Infection, Human Immunodeficiency Virus I
HIV Infection
Eligibility:
All Genders
13+ years
Phase:
PHASE3
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)-containi...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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.
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00242840
Start Date
June 1 2003
End Date
January 1 2006
Last Update
May 30 2017
Active Locations (7)
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1
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
2
GSK Investigational Site
Orlando, Florida, United States, 32804
3
GSK Investigational Site
Tampa, Florida, United States, 33614
4
GSK Investigational Site
Atlanta, Georgia, United States, 30308/30309