Fosamprenavir Expanded Access

September 9, 2016 updated by: ViiV Healthcare

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.

Study Overview

Status

Completed

Conditions

Infection, Human Immunodeficiency Virus

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Switzerland
- - 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
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ViiV Healthcare

Collaborators

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

October 14, 2005

First Submitted That Met QC Criteria

October 14, 2005

First Posted (Estimate)

October 18, 2005

Study Record Updates

Last Update Posted (Estimate)

September 12, 2016

Last Update Submitted That Met QC Criteria

September 9, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

APV40005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.