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

ViiV Healthcare

Status and phase: Completed; Phase 3

Conditions: HIV Infection; Infection, Human Immunodeficiency Virus I

Treatments: Drug: No intervention; Observational study

Study type: Interventional

Funder types: Industry

Identifiers

NCT00242840

APV30007

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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.