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

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	Phase
Infection, Human Immunodeficiency Virus	Drug: fosamprenavir Drug: Telzir®	Phase 4


Study Type:	Interventional
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

Drug Information available for: Fosamprenavir Fosamprenavir sodium Fosamprenavir calcium

U.S. FDA Resources

Further study details as provided by ViiV Healthcare:


Enrollment:	85
Study Start Date:	July 2003
Study Completion Date:	August 2005

Intervention Details:

Other Name: fosamprenavir

Eligibility


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

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
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


Responsible Party:	ViiV Healthcare
ClinicalTrials.gov Identifier:	NCT00240552 History of Changes
Other Study ID Numbers:	APV40005
Study First Received:	October 14, 2005
Last Updated:	September 9, 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

ClinicalTrials.gov processed this record on June 27, 2017

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