Fosamprenavir calcium has been approved in the United States and in the European Union and in the Other Countries

Studies listed may include approved and non-approved uses, formulations or treatment regimens. Before prescribing any product mentioned in this Register, healthcare Professionals should consult prescribing information approved in their country (view UK and US information for Healthcare Professionals).

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fosamprenavir studies

Select the study ID number to view the trial summary

Study IDPhaseTitle
APV104501 IV Pharmacokinetic study of LEXIVA® (fosamprenavir calcium hydrate) tablet in healthy Japanese male subjects.
WE066, EPI40007 IV The Antiretroviral Pregnancy Registry (APR, Registry)
APV102002 III A Phase III, Randomized, Controlled, Open-label, Multicentre, Three Arm Study to Compare the Efficacy and Safety of a Dual-boosted HIV-1 Protease Inhibitor (PI) regimen of Fosamprenavir (FPV)/ Lopinavir (LPV)/Ritonavir (RTV) 1400mg/533mg/133mg Twice Daily (BID) and an Increased Dosage Regimen of FPV/RTV 1400mg/100mg BID Versus the Standard Dosage Regimen of FPV/RTV 700mg/100mg BID for 24 Weeks in Multiple-PI Experienced, HIVinfected Adults Experiencing Virological Failure.
APV102027 III Expanded access program for fosamprenavir (FPV, GW433908) in HIV infected subjects not responding or intolerant to the previous antiretroviral treatments.
APV30001 III A Phase III, Randomized, Multicenter, Parallel, Open-Label Study to Compare the Efficacy, Safety and Tolerability of GW433908 (1400mg BID) and Nelfinavir (1250mg BID) Over 48 Weeks in Antiretroviral Therapy-Naïve HIV-1 Infected Adults
APV30002 III A Randomized, Open-Label, Two Arm Trial to Compare the Safety and Antiviral Efficacy of GW433908/Ritonavir QD to Nelfinavir BID When Used in Combination with Abacavir and Lamivudine BID for 48 Weeks in Antiretroviral Therapy Naïve HIV-1 Infected Subjects
APV30003 III A Phase III, Randomized, Multicenter, Parallel Group, Open-label, Three Arm Study to Compare the Efficacy and Safety of Two Dosing Regimens of GW433908/ritonavir (700mg/100mg twice daily or 1400mg/200mg once daily) versus lopinavir/ritonavir (400mg/100mg twice daily) for 48 Weeks in Protease Inhibitor Experienced HIV-Infected Adults Experiencing Virological Failure
APV30005 (APV30001) III Assessment of the Long-term Antiviral Response, Safety and Tolerability of FPV BID in Antiretroviral Therapy Naïve HIV-1 Infected Subjects
APV30005 (APV30002) III An Open-label, Phase III Study to Assess the Long-term Safety Profile of Fosamprenavir (FPV)-containing Regimens in HIV-1 Infected Subjects
APV30007 III A 24 Week, Phase IIIb/IV, Single Arm, Open Label, Observational Study to Explore the Efficacy of Protease Inhibitors given in Combination with Reverse Transcriptase Inhibitors to HIV-1 Infected Subjects with Protease Mutations Selected During Therapy with GW433908 Containing Antiretroviral Therapy
APV40003 III Safety and efficacy of GW433908 in antiretroviral combination therapy in patients with HIV infection
APV40004 III Expanded access programme of Fosamprenavir (gw433908) /ritonavir for patients infected by HIV.
APV40005 (SZ01V02) III 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.
APV40006 III GW433908 Open Label Study for Subjects with HIV who are Treatment Experienced, on a Failing Regimen or Intolerant to Current Therapy and Sensitive to GW433908
APVF3002 III Multicentre, open label, pilot study to evaluate genotypic sensitivity score of fosamprenavir (700mg) in combination with ritonavir (100mg) twice daily, in human immunodeficiency virus (HIV) infected patients with virological escape after first line treatment with a protease inhibitor (PI).
APVF3031 III Multicentre, randomized, comparative, open, pilot study to assess efficacy and safety of a treatment with two protease inhibitors (GW433908 + Indinavir [IDV, Crixivan®]) boosted by ritonavir (RTV, Norvir®) started simultaneously versus started with a delay of four weeks for one (IDV, Crixivan®) in combination with nucleoside reverse transcriptase inhibitor (NRTI) in experienced HIV-1 infected subjects.
APVF3032 III Efficacy and pharmacologic evaluation at Week 24 of fosamprenavir/ritonavir BID in HIV, pretreated patients switching from amprenavir/ritonavir with controlled plasma viremia.
AZL30006 III A Phase IIIb/IV, Randomized, Open Label, Multicenter, Pilot Trial to Explore the Safety and Tolerability of GW433908 +/- Ritonavir (1400mg twice daily or 700mg/100mg twice daily) When Used in Combination with a Zidovudine-containing Regimen (TRIZIVIR or COMBIVIR twice daily) Over a 24 Week Period in Antiretroviral Therapy Naive HIV-1 Infected Subjects
ESS100290 III A Phase IIIB/IV, Open-Label, Multi-Center Trial to Evaluate the Safety, Tolerability and Efficacy of HIV-1 Infected Subjects Switching Their Current Protease-Inhibitor Therapies for a Fosamprenavir Therapy Over 48 weeks.
ESS100732 III A Phase IIIB, Randomized, Open-Label, Multicenter Study of the Safety and Efficacy of GW433908 (700mg BID) plus ritonavir (100mg BID) Versus Lopinavir/ritonavir (400mg/100mg BID) when Administered in Combination with the Abacavir/Lamivudine (600mg/300mg) Fixed Dose Combination Tablet QD in Antiretroviral-Naïve HIV-1 Infected Adults Over 48 Weeks.
ESS100732 96-week results III A Phase IIIB, Randomized, Open-Label, Multicenter Study of the Safety and Efficacy of GW433908 (700mg BID) plus ritonavir (100mg BID) Versus Lopinavir/ritonavir (400mg/100mg BID) when Administered in Combination with the Abacavir/Lamivudine (600mg/300mg) Fixed-Dose Combination Tablet QD in Antiretroviral-Naive HIV-1 Infected Adults Over 48 Weeks: 96 week extension phase results.
APV20001 Open Label Phase II Open-Label Phase Report of: A Randomized, Multicenter, Partially Double-Blinded, Repeat Dose, Cross-Over Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antiviral Effect of Two Doses of FPV Compared with AGENERASEÒ (1200mg BID) when Given for 28 Days to Subjects Infected with HIV-1
ESS40001 II A Phase II, Open-Label, Randomized Study to Compare the Efficacy and Safety of EPIVIR/ZIAGEN/Zerit (3TC/ABC/d4T) Versus EPIVIR/ZIAGEN/Sustiva (3TC/ABC/EFV) Versus EPIVIR/ZIAGEN/GW433908/Norvir (3TC/ABC/908/RTV) for 96 Weeks in the Treatment of HIV-1 Infected Subjects Who are Antiretroviral Therapy Naïve.
APV10006 I A Pivotal, Phase I, Single-dose, Open-label, Randomized, Two-way Crossover Study to Assess the Bioequivalence of 2x700mg GW433908 Oral Film-coated Tablets to 3x465mg GW433908 Oral Film-coated Tablets in Healthy Adult Subjects
APV10007 I A Phase I, Single-dose, Open-label, Randomized, Three-way, Balanced, Crossover Study to Assess the Effect of MAALOX TC and ZANTAC on Plasma Amprenavir Pharmacokinetics Following Administration of a 1400mg Single Dose of GW433908
APV10008 I A Phase I, Single-dose, Open-label, Randomized, Four-period, Balanced Crossover Study to Assess the Relative Bioavailability of the GW433908 Oral Suspension Relative to the GW433908 Oral Film-coated 700mg Tablet and to Assess the Effects of Food on Amprenavir Pharmacokinetics Following Administration of these Formulations to Healthy Adult Subjects
APV10009 I A Phase I, Randomized Study to Assess the Effect of Efavirenz 600mg QD on Steady-State Plasma Total Amprenavir and Ritonavir PK Following Coadministration with GW433908 1395mg QD + Ritonavir 200mg QD or GW433908 1395mg QD + Ritonavir 300mg QD for 14 Days as Compared to GW433908 1395mg QD + Ritonavir 200mg QD for 14 Days in Healthy Adult Subjects
APV10010 I A Phase I, Randomized Study to Assess the Effect of Efavirenz 600mg QD on Steady-State Plasma Total Amprenavir Pharmacokinetics Following Co-administration with GW433908 700mg BID + Ritonavir 100mg BID or GW433908 700mg BID + Ritonavir 200mg BID for 14 Days as Compared to GW433908 700mg BID + RTV 100mg BID for 14 Days in Healthy Adult Subjects
APV10011 I A Phase I, Open, Randomized, Balanced, Incomplete Crossover Drug-Drug Interaction Study to Assess the Steady-State Plasma Amprenavir and Lopinavir Pharmacokinetics following Administration of Lopinavir 533mg/Ritonavir 133mg BID + GW433908 1400mg BID, GW433908 700mg BID + Ritonavir 100mg BID, or Lopinavir 400mg/Ritonavir 100mg BID for 14 days in Healthy Adult Subjects.
APV10012 I A Phase I, Open, Randomized, Balanced, Incomplete Crossover Drug-Drug Interaction Study to Assess the Steady-State Plasma Amprenavir and Lopinavir Pharmacokinetics following Administration of Lopinavir 400mg/Ritonavir 100mg BID + GW433908 700mg BID + Ritonavir 100mg BID, GW433908 700mg BID + Ritonavir 100mg BID, or Lopinavir 400mg/Ritonavir100mg BID for 14 days in Healthy Adult Subjects
APV10013 I A Phase I, Randomized, Open Label, Three Period, Single Sequence, Steady State, Drug-Drug Interaction Study between Atorvastatin 10mg QD and GW433908 1400mg BID and between Atorvastatin 10mg QD and GW433908 700mg BID + Ritonavir 100mg BID in Healthy Adult Subjects
APV10014 I A Phase I, Open Label, Single Arm, Three Period, Drug-Drug Interaction Study to Assess the Steady-State Plasma Amprenavir and Nevirapine Pharmacokinetics Following Administration of GW433908 1400mg BID + Nevirapine 200mg BID for 14 days and GW433908 700 mg BID + Nevirapine 200mg BID + Ritonavir 100mg BID for 14 Days in HIV-1 Infected Subjects.
APV10015 I A Pivotal, Phase I, Single-dose, Open-label, Randomized, Three Period, Balanced Crossover Study to Assess the Bioequivalence of GW433908 Oral Film-coated 700mg Tablet Formulations in Healthy Adult Subjects
APV10016 I A Pivotal, Phase I, Single-dose, Open-label, Randomized, Four Period, Balanced Crossover Study to Assess the Relative Bioavailability of the GW433908 Oral Suspension and Oral Film-coated 700mg Tablet Formulations and the Effect of Food on the Bioavailability of These Formulations in Healthy Adult Subjects
APV10018 I A Phase I, Randomized, Open Label, Four Arm, Two Period, Two 2x2, Crossover, Drug Interaction Study to Assess Steady-State Plasma Amprenavir and Atazanavir Pharmacokinetics following Administration of Fosamprenavir 700mg BID + Ritonovir 100mg BID + Atazanavir 300mg QD, Fosamprenavir 700mg BID + Ritonovir 100mg BID, and Atazanavir 300mg QD + RTV 100mg QD in Healthy Adult Subjects.
APV10020 I A Phase I, Open Label, Two Period, Single-Sequence, Drug-Drug Interaction Study Comparing Steady-State Plasma Ethinyl Estradiol and Norethisterone Pharmacokinetics following Administration of Brevinor for 21 Days with and without Fosamprenavir 700 mg Twice Daily (BID) and Ritonavir 100 mg BID for 21 Days in Healthy Adult Female Subjects
APV10021 I A Pivotal, Phase I, Single-dose, Open-label, Randomized, Two-Period, Balanced Crossover Study to Assess the Bioequivalence of GW433908 Oral Film-coated 700mg Tablets in Healthy Adult Subjects
APV10022 I A Phase I, Randomized, Open Label, Two-Period, Four-Arm, Balanced Cross-over, Steady-state, Drug Interaction Study between Ritonavir 100mg BID and FPV 700mg BID and between Ritonavir 100mg BID and AGENERASE† 600mg BID in Healthy Adult Subjects
APV10023 I A Pivotal, Phase I, Open-label, Randomized, Four-Period, Single and Multiple Dose, Crossover Study to Assess the Bioequivalence of Two GW433908 700mg Oral Film-coated Tablet Variants Following Administration of Single 1400mg Doses and Following Administration of 1400mg BID for 14 Days in Healthy Adult Subjects..
APV10024 I A Pivotal, Phase I, Open-label, Randomized, Four-Period, Two-Part, Crossover Study to Assess the Relative Bioavailability of the Fosamprenavir 50mg/mL Oral Suspension and 700mg Oral Film-coated Tablet Formulations Following Administration of Single 1400mg Doses and Following Administration of 1400mg BID for 10 days in Healthy Adult Subjects.
APV10025 I A Phase I, Randomized, Open Label, Two Period, Two Sequence, Drug-Drug Interaction Study Comparing Steady-State Plasma Rifabutin Pharmacokinetics following Coadministration of Fosamprenavir 700mg + Ritonavir 100mg Twice Daily (BID) and Rifabutin 150mg Every Other Day (QOD) and following Administration of Rifabutin 300 mg Once Daily (QD) in Healthy Adult Subjects.
APV10026 I A Phase I, Open-Label, Single-Sequence, Drug-Drug Interaction Study Comparing Ketoconazole and Amprenavir Pharmacokinetics Following Administration of Ketoconazole 200 mg QD for Four Days, Fosamprenavir 700mg BID + Ritonavir 100mg BID for Ten Days, and Ketoconazole 200 mg QD + Fosamprenavir 700mg BID + Ritonavir 100mg BID for Four Days in Healthy Adult Subjects
APV10028 I A Phase I, Open, Randomized, Balanced, Three-Period, Crossover, Steady-State, Pharmacokinetic Study Comparing GW433908 1400mg BID + RTV 100mg BID, GW433908 1400mg BID + RTV 200mg BID, and GW433908 700mg BID + RTV 100mg BID Regimens in Healthy Adult Subjects
APV10029 I A Phase I, Open-label, Randomized, Two-Period, Balanced Crossover, Study to Compare Steady-State Plasma Amprenavir Pharmacokinetics following administration of Two GW433908 Tablet Variants, Each administered as 1400mg QD in Combination with Ritonavir 200mg QD in Healthy Adult Subjects
APV10031 I A Phase I, Randomized, Open Label, Two Arm, Three Period, Drug-Drug Interaction Study Comparing Steady-State Plasma Amprenavir and Esomeprazole Pharmacokinetics following Coadministration of GW433908 1400mg BID and Esomeprazole 20mg QD and following Coadministration of GW433908 700mg BID + RTV 100mg BID and Esomeprazole 20mg QD in Healthy Adult Subjects.
APV107484 I A Phase I, Randomized, Open Label, Four Arm, Two Period, Two 2X2, Crossover, Drug Interaction Study to Assess Steady-State Plasma Amprenavir and Phenytoin Pharmacokinetics following Administraction of Fosamprenavir 700mg BID + Ritonavir 100mg BID + Phenytoin 300mg QD, Fosamprenavir 700mg BID + Ritonavir 1--mg BID, Phenytoin 300mg QD in Healthy Adult Subjects
COL20081 I A Phase I, Randomised, Open Label, Steady-State Cross-Over Drug Interaction Study to Assess the Influence of Tenofovir DF on the Pharmacokinetics of Amprenavir when given as GW433908/RTV 1400mg/200mg and GW433908/RTV 1400mg/100mg after Multiple Doses in Healthy Volunteers
COL40287 I The Pharmacokinetic Interaction of a Triple Protease Inhibitor Regimen Containing Fosamprenavir, Lopinavir, and Ritonavir in Healthy Volunteers
NN210010 I A Phase I, Open Label, Randomized, Three Cohort Study to Investigate the Potential Pharmacokinetic Interaction, Safety and Tolerability of GW695634G 400mg q12h and Three Ritonavir-boosted HIV-1 Protease Inhibitors (Atazanavir, Fosamprenavir and Lopinavir) Following Oral Administration to Healthy Adult Subjects.