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

Tracking Information

First Received Date ^ICMJE

October 14, 2005

Last Updated Date

October 15, 2008

Start Date ^ICMJE

July 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Incidence and frequency of serious adverse events

Change History

Complete list of historical versions of study NCT00240552 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Incidence and frequency of adverse events with at least possible causality leading to permanent fosamprenavir discontinuation.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Fosamprenavir Expanded Access

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Expanded Access

Study Phase

Not Provided

Study Design ^ICMJE

Not Provided

Condition ^ICMJE

HIV Infection

Intervention ^ICMJE

Drug: fosamprenavir
Drug: Telzir®
Other Names:
- fosamprenavir
- Telzir®

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

No longer available

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT Number ^ICMJE

NCT00240552

Other Study ID Numbers ^ICMJE

APV40005, SZ01V02

Has Data Monitoring Committee

Not Provided

Responsible Party

Study Director, GSK

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

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

To Top