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Fosamprenavir Expanded Access

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ClinicalTrials.gov Identifier: NCT00240552
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : September 12, 2016
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : July 2003
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

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

Arms and Interventions
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Intervention Details:
    Drug: fosamprenavir Drug: Telzir®
    Other Name: fosamprenavir

Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00240552


Locations
Switzerland
GSK Investigational Site
Aarau, Switzerland, 5001
GSK Investigational Site
Basel, Switzerland, 4031
GSK Investigational Site
Bern, Switzerland, 3010
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
GSK Investigational Site
Zurich, Switzerland, 8091
Sponsors and Collaborators
ViiV Healthcare
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials ViiV Healthcare
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00240552     History of Changes
Other Study ID Numbers: APV40005
First Posted: October 18, 2005    Key Record Dates
Last Update Posted: September 12, 2016
Last Verified: September 2016

Keywords provided by ViiV Healthcare:
protease inhibitor
Treatment Experienced
amprenavir
fosamprenavir
 GW433908
HIV
pro drug

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Slow Virus Diseases
Fosamprenavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents