Fosamprenavir Expanded Access
Primary Purpose
Infection, Human Immunodeficiency Virus
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
fosamprenavir
Telzir®
Sponsored by
About this trial
This is an interventional trial for Infection, Human Immunodeficiency Virus focused on measuring protease inhibitor, Treatment Experienced, amprenavir, fosamprenavir, GW433908, HIV, pro drug
Eligibility Criteria
Inclusion Criteria: HIV-1 infected subjects. Subjects must belong to one of the following populations: Subjects with limited treatment options due to viral resistance, interactions, or tolerability issues with other antiretroviral drugs. Subjects who already receive amprenavir (Agenerase®) Subjects for whom once daily dosing of antiretroviral therapy is indicated, including, once daily dosing with fosamprenavir/ritonavir.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00240552
First Posted
October 14, 2005
Last Updated
September 9, 2016
Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00240552
Brief Title
Fosamprenavir 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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Human Immunodeficiency Virus
Keywords
protease inhibitor, Treatment Experienced, amprenavir, fosamprenavir, GW433908, HIV, pro drug
7. Study Design
Study Phase
Phase 4
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
fosamprenavir
Intervention Type
Drug
Intervention Name(s)
Telzir®
Other Intervention Name(s)
fosamprenavir
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HIV-1 infected subjects.
Subjects must belong to one of the following populations:
Subjects with limited treatment options due to viral resistance, interactions, or tolerability issues with other antiretroviral drugs.
Subjects who already receive amprenavir (Agenerase®)
Subjects for whom once daily dosing of antiretroviral therapy is indicated, including, once daily dosing with fosamprenavir/ritonavir.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
ViiV Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
GSK Investigational Site
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
GSK Investigational Site
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
GSK Investigational Site
City
Bruderholz
ZIP/Postal Code
4101
Country
Switzerland
Facility Name
GSK Investigational Site
City
La Chaux-de-Fonds
ZIP/Postal Code
CH 2301
Country
Switzerland
Facility Name
GSK Investigational Site
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
GSK Investigational Site
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Facility Name
GSK Investigational Site
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland
Facility Name
GSK Investigational Site
City
St Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
GSK Investigational Site
City
Zurich
ZIP/Postal Code
8008
Country
Switzerland
Facility Name
GSK Investigational Site
City
Zurich
ZIP/Postal Code
8038
Country
Switzerland
Facility Name
GSK Investigational Site
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
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Fosamprenavir Expanded Access
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