NCT00240552

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2003

Typical duration for phase_4

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2005

Completed
Last Updated

September 12, 2016

Status Verified

September 1, 2016

First QC Date

October 14, 2005

Last Update Submit

September 9, 2016

Conditions

Infection, Human Immunodeficiency Virus

Keywords

protease inhibitorTreatment ExperiencedamprenavirfosamprenavirGW433908HIVpro drug

Interventions

fosamprenavirDRUG
Telzir®DRUG
Also known as: fosamprenavir

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

GSK Investigational Site

Aarau, 5001, Switzerland

Location

GSK Investigational Site

Basel, 4031, Switzerland

Location

GSK Investigational Site

Bern, 3010, Switzerland

Location

GSK Investigational Site

Bruderholz, 4101, Switzerland

Location

GSK Investigational Site

La Chaux-de-Fonds, CH 2301, Switzerland

Location

GSK Investigational Site

Lausanne, 1011, Switzerland

Location

GSK Investigational Site

Lucerne, 6000, Switzerland

Location

GSK Investigational Site

Lugano, 6900, Switzerland

Location

GSK Investigational Site

Sankt Gallen, 9007, Switzerland

Location

GSK Investigational Site

Zurich, 8008, Switzerland

Location

GSK Investigational Site

Zurich, 8038, Switzerland

Location

GSK Investigational Site

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

InfectionsAcquired Immunodeficiency Syndrome

Interventions

fosamprenavir

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • GSK Clinical Trials

    ViiV Healthcare

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2005

First Posted

October 18, 2005

Study Start

July 1, 2003

Study Completion

August 1, 2005

Last Updated

September 12, 2016

Record last verified: 2016-09

Locations

CH(12)