A Study To Assess GW433908 (Fosamprenavir) Containing Regimens In HIV-1 Infected Subjects

ViiV Healthcare

Status and phase

Completed

Phase 3

Conditions

Infection, Human Immunodeficiency Virus

Treatments

Drug: fosamprenavir (GW433908)

Drug: ritonavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00296504

APV30005

Details and patient eligibility

About

GW433908 (fosamprenavir; FPV)is a pro-drug of amprenavir (APV) which is more water soluble and can be formulated into a tablet with a reduced pill burden (four 700mg tablets of FPV versus sixteen 150mg capsules daily for APV. This study is designed to provide additional information on long term safety and tolerability of FPV containing regimens for those subjects who received FPV in previous GlaxoSmithKline studies.

Full description

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.

Enrollment

753 patients

Sex

All

Ages

13+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or non-pregnant/non-lactating females >/=13 years of age (or >/= 18 years of age according to local requirements).
Received fosamprenavir through prior participation in APV20001, APV30002, APV30003 or PRO30017 or have participated in APV30001 or other studies as deemed appropriate by the project team.

Exclusion criteria

Permanent discontinuation of GW433908 in a previous study due to intolerance.
An active CDC Class C Event.
Any condition which, in the opinion of the investigator, would preclude a subject from participation.