Overview

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

Status:
Completed
Trial end date:
2010-10-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
ViiV Healthcare
Collaborator:
GlaxoSmithKline
Treatments:
Fosamprenavir
Ritonavir
Criteria
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.