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Study ID Status Title Patient Level Data
APV10008 Completed 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 Administr ...
APV10009 Completed 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 + Riton ...
APV10010 Completed 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 + RT ...
APV10011 Completed 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…
APV10012 Completed 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 + Rit ...
APV10013 Completed 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 Completed 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 ...
APV10015 Completed 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 Completed 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 Adul ...
APV10017 Completed A Phase I, Parallel, Open-label, Multicenter, Two-Week, Repeat-dose Study Evaluating Plasma Amprenavir Pharmacokinetics in HIV-1-infected Adult Subjects with Mild, Moderate or Severe Hepatic Impairment Receiving Fosamprenavir + Ritonavir Compared to Matched Control Subjects with Normal Hepatic Function
APV10018 Completed 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 + ...
APV10020 Completed 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 fo ...
APV10021 Completed 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 Completed 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 Completed 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…
APV10024 Completed 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 14 ...
APV10025 Completed 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 Administ ...
APV10026 Completed 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 700m ...
APV10028 Completed 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 Completed 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 Completed 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 1 ...
APV102002 Completed 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 regimen of Fosamprenavir/Lopinavir/Ritonavir 1400mg/533mg/133mg Twice Daily 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, HIV-infected Adults Experiencing Virological Failure
APV109141 Completed Study of Once-Daily Versus Twice-Daily Fosamprenavir plus Ritonavir, Administered with Abacavir/Lamivudine Once-Daily in Antiretroviral-Naive HIV-1 Infected Adult Subjects.
APV20001 Completed 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 AGENERASE(1200mg BID) when Given for 28 Days to Subjects Infected with HIV-1
APV20002 Active, Not Recruiting A 48 week, Phase II, open-label, 2-cohort, multicenter study to evaluate the pharmacokinetics, safety, tolerability and antiviral activity of GW433908 and GW433908/RTV when administered to HIV-1 infected protease inhibitor (PI) naive and PI-experienced pediatric subjects aged 4 weeks to <2 years.

 

 

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