Status:
COMPLETED
Fosamprenavir Expanded Access
Lead Sponsor:
ViiV Healthcare
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Infection, Human Immunodeficiency Virus
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00240552
Start Date
July 1 2003
End Date
August 1 2005
Last Update
September 12 2016
Active Locations (12)
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1
GSK Investigational Site
Aarau, Switzerland, 5001
2
GSK Investigational Site
Basel, Switzerland, 4031
3
GSK Investigational Site
Bern, Switzerland, 3010
4
GSK Investigational Site
Bruderholz, Switzerland, 4101