Observational Study Of A Protease Inhibitor (PI) Containing Regimen In Subjects With PI Mutations Selected During Prior Treatment With GW433908 (Fosamprenavir)
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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.
Condition or disease
Infection, Human Immunodeficiency Virus IHIV Infection
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
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
13 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.