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Protocol Summaries: fosamprenavir

Study ID
   Phase    Title Status
100290 phase 3 A phase IIIB/IV, open-label, multi-center trial to evaluate the safety, tolerability, and efficiency of HIV-1 infected subjects switching their current protease-inhibitor therapies for a fosamprenavir therapy over 48 weeks Completed
100732 phase 3 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 Completed
102577 Phase 1 A Phase I, Open-Label, 2-Period, Single-Sequence, Drug Interaction Study to Assess Steady-State Plasma Methadone Enantiomer Pharmacokinetics Following Co-Administration of Methadone QD with Fosamprenavir 700mg BID + RTV 100mg BID in Opiate-Dependent, HIV Seronegative, Adult Subjects Completed
112334 Phase 2 Drug Use Investigation for Lexiva tablet (HRD Cooperative Investigation) Completed
112346 Phase 2 Special Drug Use Investigation for Lexiva tablet (Pregnancy) (HRD Cooperative Investigation) Completed
112880 N/A An observational multi-cohort study on the use of Fosamprenavir-Ritonavir among HIV-infected children and adolescents in Europe Completed
APV 20003 Phase 2 See Detailed Description Completed
APV10017 phase 1 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 Completed
APV102002 phase 3 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 Completed
APV109141 phase 3 Study of Once-Daily Versus Twice-Daily Fosamprenavir plus Ritonavir, Administered with Abacavir/Lamivudine Once-Daily in Antiretroviral-Naive HIV-1 Infected Adult Subjects. Completed
APV20002 phase 2 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. Active not recruiting
APV29005 phase 2 A 48 Week, Phase II, Non-Comparative, Open-label, Multi-Cohort, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GW433908/Ritonavir BID when Administered to HIV-1 infected, PI-Naïve and Experienced, Pediatric Subjects, 2 to 18 Years Old and of GW433908 BID Administered to PI-Naïve, Pediatric Subjects 2 to < 6 Years Old Completed
APV30005 phase 3 An Open-Label Phase III Study to Assess the Long Term Safety Profile of GW433908 Containing Regimens in HIV-1 Infected Subjects Completed
APV30007 phase 3 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 Completed
APV40005 phase 4 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 Completed
LEX106430 phase 3 A Phase IIIB, randomized, open-label, parallel group, multi-center, non-inferiority, 24-week study to evaluate the safety, efficacy and tolerability of switching from a 200mg ritonavir-boosted regimen of LEXIVA (700mg/100mg BID or 1400mg/200mg QD) to a once-daily, 100mg ritonavir-boosted regimen of LEXIVA (1400mg/100mg QD) Completed
NN210005 Phase 1 A Phase I, Multicenter, Randomized, Parallel, Double-Blinded Dose Ranging, Placebo-Controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of Four Oral Dosage Regimens of GW695634G Monotherapy Versus Placebo Over 10 days in ART-Naive HIV-1 Infected Adults. Completed