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Fosamprenavir Expanded Access

Primary Purpose

Infection, Human Immunodeficiency Virus

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
fosamprenavir
Telzir®
Sponsored by
ViiV Healthcare
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 14, 2005
Last Updated
September 9, 2016
Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline
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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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