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NCT00240552 Clinical Trial

Fosamprenavir Expanded Access

Infection, Human Immunodeficiency Virus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00240552
Other study ID # APV40005
Secondary ID
Status Completed
Phase Phase 4
First received October 14, 2005
Last updated September 9, 2016
Start date July 2003
Est. completion date August 2005

Study information
Verified date September 2016
Source ViiV Healthcare
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 85
Est. completion date August 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- HIV-1 infected subjects.

- Subjects must belong to one of the following populations:

1. Subjects with limited treatment options due to viral resistance, interactions, or tolerability issues with other antiretroviral drugs.

2. Subjects who already receive amprenavir (Agenerase®)

3. Subjects for whom once daily dosing of antiretroviral therapy is indicated, including, once daily dosing with fosamprenavir/ritonavir.

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Drug:
• fosamprenavir

• Telzir®

Locations
Country Name City State
Switzerland GSK Investigational Site Aarau
Switzerland GSK Investigational Site Basel
Switzerland GSK Investigational Site Bern
Switzerland GSK Investigational Site Bruderholz
Switzerland GSK Investigational Site La Chaux-de-Fonds
Switzerland GSK Investigational Site Lausanne
Switzerland GSK Investigational Site Lugano
Switzerland GSK Investigational Site Luzern
Switzerland GSK Investigational Site St Gallen
Switzerland GSK Investigational Site Zurich
Switzerland GSK Investigational Site Zurich
Switzerland GSK Investigational Site Zurich

Sponsors (2)
Lead Sponsor Collaborator
ViiV Healthcare GlaxoSmithKline

Country where clinical trial is conducted

Switzerland, 

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