NEWS HIGHLIGHTSMedia Articles Related to Lexiva (Fosamprenavir)
fosamprenavir-oral, Lexiva
Source: MedicineNet atazanavir Specialty [2005.03.02]
Title: fosamprenavir-oral, Lexiva
Category: Medications
Created: 3/2/2005
Last Editorial Review: 3/2/2005
Published Studies Related to Lexiva (Fosamprenavir)
Pharmacokinetics of concurrent administration of fosamprenavir and atazanavir without ritonavir in human immunodeficiency virus-negative subjects. [2009.08]
STUDY OBJECTIVE: To quantify the pharmacokinetics of amprenavir and atazanavir (administered as the prodrug fosamprenavir) alone and in combination in human immunodeficiency virus (HIV)-negative subjects... CONCLUSION: Atazanavir 400 mg/day plus fosamprenavir 1400 mg/day significantly decreased concentrations of atazanavir compared with standard dosing regimens of each drug alone. This dosing scheme is not a recommended combination of dual, fully active protease inhibitors.
Fosamprenavir/ritonavir in advanced HIV disease (TRIAD): a randomized study of high-dose, dual-boosted or standard dose fosamprenavir/ritonavir in HIV-1-infected patients with antiretroviral resistance. [2009.08]
BACKGROUND: APV102002 was an open-label study comparing a dual-boosted HIV-1 protease inhibitor (PI) [fosamprenavir/lopinavir/ritonavir (FPV/LPV/RTV; 1400 mg/533 mg/133 mg twice daily)] and a high dose of FPV/RTV 1400 mg/100 mg twice daily (HD-FPV/RTV) versus the standard FPV/RTV 700 mg/100 mg twice-daily (STD-FPV/RTV) regimen for 24 weeks... CONCLUSIONS: While the strategies of higher dose FPV/RTV and dual FPV/LPV/RTV were relevant at the time of study initiation, new therapies for antiretroviral-experienced patients make such strategies of limited interest. In addition, this study failed to demonstrate antiviral superiority of the HD-FPV/RTV or FPV/LPV/RTV regimen over the STD-FPV/RTV twice-daily regimen in highly treatment-experienced patients.
Comparison of once-daily fosamprenavir boosted with either 100 or 200 mg of ritonavir, in combination with abacavir/lamivudine: 96-week results from COL100758. [2009.04]
The long-term efficacy of once-daily (qd) fosamprenavir (FPV) 1400 mg boosted by ritonavir 100 mg (FPV/r100) has not been evaluated previously. A 96-week open-label, randomized, multicenter study compared the efficacy/safety of FPV/r100 with FPV 1400 mg boosted by ritonavir 200 mg qd (FPV/r200), plus abacavir/lamivudine 600 mg/300 mg qd, in antiretroviral-naive, HIV-infected patients with viral load (VL)> or =1000 copies/ml...
Long-term efficacy and safety of fosamprenavir plus ritonavir versus lopinavir/ritonavir in combination with abacavir/lamivudine over 144 weeks. [2009.03]
PURPOSE: The KLEAN study extension assessed the long-term efficacy and safety of fosamprenavir-ritonavir (FPV/r) and lopinavir-ritonavir (LPV/r), both administered with abacavir/lamivudine (ABC/3TC) fixed dose combination, over 144 weeks... CONCLUSION: The findings of the KLEAN study extension (48 to 144 weeks) support durable viral suppression with both FPV/r and LPV/r treatment regimens when used in combination with ABC/3TC irrespective of viral load at baseline. Both regimens were well tolerated and had similar safety profiles.
Genotypic resistance analysis of the virological response to fosamprenavir-ritonavir in protease inhibitor-experienced patients in CONTEXT and TRIAD clinical trials. [2008.12]
The aim of this study was to identify human immunodeficiency virus (HIV) protease mutations associated with virological response (VR) to fosamprenavir-ritonavir (FPV/r) in 113 protease inhibitor (PI)-experienced patients randomized in both CONTEXT and TRIAD clinical trials and receiving the same dose (700/100 mg twice daily) of FPV/r...
Clinical Trials Related to Lexiva (Fosamprenavir)
A Study To Assess GW433908 (Fosamprenavir) Containing Regimens In HIV-1 Infected Subjects [Completed]
GW433908 (fosamprenavir; FPV)is a pro-drug of amprenavir (APV) which is more water soluble
and can be formulated into a tablet with a reduced pill burden (four 700mg tablets of FPV
versus sixteen 150mg capsules daily for APV. This study is designed to provide additional
information on long term safety and tolerability of FPV containing regimens for those
subjects who received FPV in previous GlaxoSmithKline studies.
Fosamprenavir Expanded Access [No longer available]
This open-label study will enable HIV-infected adults with limited treatment options to
receive fosamprenavir until commercial supplies are available in Switzerland.
KALETRA Or LEXIVA With Ritonavir Combined With EPIVIR And Abacavir In Naive Subjects Over 48 Weeks [Completed]
This study will compare the ability of fosamprenavir 700 mg with ritonavir 100 mg twice a
day or lopinavir 400 mg with ritonavir 100 mg twice a day both combined with a fixed dose
combination tablet of abacavir 600 mg and lamivudine 300 mg once a day to suppress virus
levels of HIV to less than 400 copies/mL of blood. In addition we will study the safety and
tolerability of these compounds over the 48 week study period in patients naive to anti-HIV
therapy.
Fosamprenavir Versus Other Protease Inhibitors [Completed]
This study was designed to evaluate and compare safety, tolerability of subjects who
successfully suppress HIV-1 on their first PI regimen to those who switch to fosamprenavir.
This is a 48-week study, where subjects who were assigned to be in their original PI-group
have the option of switching to fosamprenavir on week 24. Prior to being assigned their
treatment group, subjects had to be suppressed for at least three months. All subjects also
take a background regimen of two nucleoside/nucleotide reverse transcriptase inhibitors.
Open Label Study of 908/RTV in Combination With Other PIs for the Treatment of Multi PI-Experienced HIV Subjects [Terminated]
For HIV-infected individuals with highly resistant viruses, higher drug levels may be
required to block the virus. This study investigates that concept by comparing the efficacy
of standard fosamprenavir/ritonavir to an increased dose of boosted fosamprenavir and to a
combination of fosamprenavir (increased dose)/lopinavir/ritonavir.
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