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Fosamprenavir Expanded Access

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00240552
First received: October 14, 2005
Last updated: September 9, 2016
Last verified: September 2016

October 14, 2005
September 9, 2016
July 2003
Not Provided
Not Provided
Incidence and frequency of serious adverse events
Complete list of historical versions of study NCT00240552 on ClinicalTrials.gov Archive Site
Not Provided
Incidence and frequency of adverse events with at least possible causality leading to permanent fosamprenavir discontinuation.
Not Provided
Not Provided
 
Fosamprenavir Expanded Access
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
This open-label study will enable HIV-infected adults with limited treatment options to receive fosamprenavir until commercial supplies are available in Switzerland.
Not Provided
Interventional
Phase 4
Not Provided
Infection, Human Immunodeficiency Virus
  • Drug: fosamprenavir
  • Drug: Telzir®
    Other Name: fosamprenavir
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
August 2005
Not Provided

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00240552
APV40005
Not Provided
Not Provided
Not Provided
ViiV Healthcare
ViiV Healthcare
GlaxoSmithKline
Study Director: GSK Clinical Trials ViiV Healthcare
ViiV Healthcare
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP