Fosamprenavir Expanded Access

Expanded access is no longer available for this treatment.
Information provided by:
GlaxoSmithKline Identifier:
First received: October 14, 2005
Last updated: October 15, 2008
Last verified: October 2008
This open-label study will enable HIV-infected adults with limited treatment options to receive fosamprenavir until commercial supplies are available in Switzerland.

Condition Intervention
HIV Infection
Drug: fosamprenavir
Drug: Telzir®

Study Type: Expanded Access     What is Expanded Access?
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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Study Start Date: July 2003
Intervention Details:
    Drug: fosamprenavir Drug: Telzir®
    Other Name: fosamprenavir

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00240552

GSK Investigational Site
Aarau, Switzerland, 5001
GSK Investigational Site
Basel, Switzerland, 4031
GSK Investigational Site
Bruderholz, Switzerland, 4101
GSK Investigational Site
La Chaux-de-Fonds, Switzerland, CH 2301
GSK Investigational Site
Lausanne, Switzerland, 1011
GSK Investigational Site
Lugano, Switzerland, 6900
GSK Investigational Site
Luzern, Switzerland, 6000
GSK Investigational Site
St Gallen, Switzerland, 9007
GSK Investigational Site
Zurich, Switzerland, 8008
GSK Investigational Site
Zurich, Switzerland, 8038
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

Responsible Party: Study Director, GSK Identifier: NCT00240552     History of Changes
Other Study ID Numbers: APV40005  SZ01V02 
Study First Received: October 14, 2005
Last Updated: October 15, 2008
Health Authority: Switzerland: Swissmedic

Keywords provided by GlaxoSmithKline:
pro drug
protease inhibitor
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents processed this record on August 24, 2016