Fosamprenavir Expanded Access

Sponsor

ViiV Healthcare (Industry)

Overall Status

Completed

CT.gov ID

NCT00240552

Collaborator

GlaxoSmithKline (Industry)

Enrollment

Locations

Duration (Months)

7.1

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This open-label study will enable HIV-infected adults with limited treatment options to receive fosamprenavir until commercial supplies are available in Switzerland.

Condition or Disease	Intervention/Treatment	Phase
Infection, Human Immunodeficiency Virus	Drug: fosamprenavir Drug: Telzir®	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

85 participants

Official Title:

An Open-label Phase III Study to Provide Access to Fosamprenavir and to Assess the Long Term Safety and Tolerability of Fosamprenavir Containing Regimens in HIV Infected Patients With Limited Treatment Options

Study Start Date :

Jul 1, 2003

Actual Study Completion Date :

Aug 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

HIV-1 infected subjects.
Subjects must belong to one of the following populations:

Subjects with limited treatment options due to viral resistance, interactions, or tolerability issues with other antiretroviral drugs.
Subjects who already receive amprenavir (Agenerase®)
Subjects for whom once daily dosing of antiretroviral therapy is indicated, including, once daily dosing with fosamprenavir/ritonavir.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	GSK Investigational Site	Aarau	Switzerland	5001
2	GSK Investigational Site	Basel	Switzerland	4031
3	GSK Investigational Site	Bern	Switzerland	3010
4	GSK Investigational Site	Bruderholz	Switzerland	4101
5	GSK Investigational Site	La Chaux-de-Fonds	Switzerland	CH 2301
6	GSK Investigational Site	Lausanne	Switzerland	1011
7	GSK Investigational Site	Lugano	Switzerland	6900
8	GSK Investigational Site	Luzern	Switzerland	6000
9	GSK Investigational Site	St Gallen	Switzerland	9007
10	GSK Investigational Site	Zurich	Switzerland	8008
11	GSK Investigational Site	Zurich	Switzerland	8038
12	GSK Investigational Site	Zurich	Switzerland	8091