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Fosamprenavir Expanded Access

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00240552
First received: October 14, 2005
Last updated: October 15, 2008
Last verified: October 2008
History of Changes
  Purpose

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:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:
Study Start Date: July 2003
Intervention Details:
    Drug: fosamprenavir Drug: Telzir®
    Other Names:
    • fosamprenavir
    • Telzir®
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00240552

Locations
Switzerland
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
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov 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:
GW433908
pro drug
fosamprenavir
amprenavir
 protease inhibitor
HIV
Treatment Experienced

Additional relevant MeSH terms:
Fosamprenavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
 HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015