Overview

Observational Study Of A Protease Inhibitor (PI) Containing Regimen In Subjects With PI Mutations Selected During Prior Treatment With GW433908 (Fosamprenavir)

Status:
Completed
Trial end date:
2006-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
ViiV Healthcare
Treatments:
Fosamprenavir
HIV Protease Inhibitors
Protease Inhibitors
Reverse Transcriptase Inhibitors
Criteria
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.