MedPath

Fosamprenavir

Generic Name
Fosamprenavir
Brand Names
Lexiva, Telzir
Drug Type
Small Molecule
Chemical Formula
C25H36N3O9PS
CAS Number
226700-79-4
Unique Ingredient Identifier
WOU1621EEG
Background

Fosamprenavir is a prodrug of amprenavir, an inhibitor of human immunodeficiency virus (HIV) protease.

Indication

Indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection, as well as postexposure prophylaxis of HIV infection in individuals who have had occupational or nonoccupational exposure to potentially infectious body fluids of a person known to be infected with HIV when that exposure represents a substantial risk for HIV transmission. The use of fosamprenavir is pending revision due to a potential association between the drug and myocardial infarction and dyslipidemia in HIV infected adults.

Associated Conditions
Human Immunodeficiency Virus Type 1 (HIV-1) Infection

A Study of an Investigational Regimen Combining FDA Approved HIV Drugs in HIV-Infected Subjects

Phase 3
Completed
Conditions
HIV Infection
Infection, Human Immunodeficiency Virus
Interventions
First Posted Date
2006-08-15
Last Posted Date
2010-11-05
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
211
Registration Number
NCT00363142
Locations
🇵🇷

GSK Investigational Site, San Juan, Puerto Rico

A Study To Assess GW433908 (Fosamprenavir) Containing Regimens In HIV-1 Infected Subjects

Phase 3
Completed
Conditions
Infection, Human Immunodeficiency Virus
First Posted Date
2006-02-27
Last Posted Date
2013-04-19
Lead Sponsor
ViiV Healthcare
Target Recruit Count
753
Registration Number
NCT00296504
Locations
🇬🇧

GSK Investigational Site, London, United Kingdom

"The Once A Day Protease Inhibitor Regimens"

Phase 4
Completed
Conditions
HIV Infections
Interventions
First Posted Date
2005-10-19
Last Posted Date
2014-01-15
Lead Sponsor
The University of Texas Health Science Center, Houston
Target Recruit Count
76
Registration Number
NCT00242216
Locations
🇺🇸

Thomas Street Health Center, Houston, Texas, United States

Fosamprenavir Expanded Access

Phase 4
Completed
Conditions
Infection, Human Immunodeficiency Virus
First Posted Date
2005-10-18
Last Posted Date
2016-09-12
Lead Sponsor
ViiV Healthcare
Target Recruit Count
85
Registration Number
NCT00240552
Locations
🇨🇭

GSK Investigational Site, Zurich, Switzerland

Dual Boosted Protease Inhibitor Regimens Without Any Additional Antiretroviral Therapy in HIV-1 Infected Patients (ANRS127)

Phase 2
Completed
Conditions
HIV Infections
Interventions
First Posted Date
2005-07-22
Last Posted Date
2011-12-22
Lead Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Target Recruit Count
61
Registration Number
NCT00122603
Locations
🇫🇷

Service des Maladies infectieuses et tropicales Hopital Bichat Claude Bernard, Paris, France

Fosamprenavir Versus Other Protease Inhibitors

Phase 3
Completed
Conditions
Infection, Human Immunodeficiency Virus I
Interventions
First Posted Date
2004-10-21
Last Posted Date
2018-04-18
Lead Sponsor
ViiV Healthcare
Target Recruit Count
314
Registration Number
NCT00094523
Locations
🇵🇷

GSK Investigational Site, Ponce, Puerto Rico

48-Week Study Of GW433908 And Ritonavir Or GW433908 Alone, Twice Daily In Pediatric Patients With HIV Infection

Phase 2
Completed
Conditions
Infection, Human Immunodeficiency Virus I
Interventions
First Posted Date
2004-08-10
Last Posted Date
2017-03-07
Lead Sponsor
ViiV Healthcare
Target Recruit Count
110
Registration Number
NCT00089583
Locations
🇪🇸

GSK Investigational Site, Vigo ( Pontevedra), Spain

KALETRA Or LEXIVA With Ritonavir Combined With EPIVIR And Abacavir In Naive Subjects Over 48 Weeks

Phase 3
Completed
Conditions
HIV Infection
Infection, Human Immunodeficiency Virus
First Posted Date
2004-06-21
Last Posted Date
2011-05-16
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
866
Registration Number
NCT00085943
Locations
🇨🇭

GSK Investigational Site, St Gallen, Switzerland

Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects

Phase 2
Completed
Conditions
Infection, Human Immunodeficiency Virus
HIV Infections
Interventions
First Posted Date
2003-10-31
Last Posted Date
2023-10-10
Lead Sponsor
ViiV Healthcare
Target Recruit Count
59
Registration Number
NCT00071760
Locations
🇿🇦

GSK Investigational Site, Soweto, South Africa

Study to Explore Safety And Tolerability of Fosamprenavir With or Without Ritonavir in Combination With TRIZIVIR or COMBIVIR

Phase 3
Completed
Conditions
HIV Infections
First Posted Date
2002-08-19
Last Posted Date
2013-02-12
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
60
Registration Number
NCT00043888
Locations
🇬🇧

GSK Clinical Trials Call Center, Manchester, United Kingdom

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