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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00242840

Enrollment

Registered

2005-10-21

Start date

2003-06-30

Completion date

2006-01-31

Last updated

2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection, Infection, Human Immunodeficiency Virus I

Keywords

protease inhibitor, ritonavir, GW433908, HIV-1, fosamprenavir

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.

Interventions

DRUGNo intervention; Observational study

Eligibility

Sex/Gender

ALL

Age

13 Years to No maximum

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.

Countries

Italy, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026