Bictegravir-Tenofovir alafenamide-Emtricitabine Biktarvy
Darunavir-Cobicistat-Tenofovir alafenamide-Emtricitabine Symtuza
Dolutegravir-Abacavir-Lamivudine Triumeq
Dolutegravir-Lamivudine Dovato
Dolutegravir-Rilpivirine Juluca
Doravirine-Tenofovir DF-Lamivudine Delstrigo
Efavirenz-Tenofovir DF-Emtricitabine Atripla
Elvitegravir-Cobicistat-Tenofovir alafenamide-Emtricitabine Genvoya
Elvitegravir-Cobicistat-Tenofovir DF-Emtricitabine Stribild
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Maraviroc Selzentry
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Abacavir-Lamivudine-Zidovudine Trizivir
Didanosine Videx
Emtricitabine Emtriva
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Tenofovir alafenamide-Emtricitabine Descovy
Tenofovir DF Viread
Tenofovir DF-Emtricitabine Truvada and Multiple Generics
Zidovudine Retrovir
Zidovudine-Lamivudine Combivir
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Common TitleALERT Industry
Treatments
Fosamprenavir
Fosamprenavir
Tradename:LexivaOther Names:FPVClass:Protease Inhibitors (PI)Categories Treatment-Naive
Funding
IndustryGlaxoSmithKline
References
- Smith KY, Weinberg WG, Dejesus E, et al. Fosamprenavir or atazanavir once daily boosted with ritonavir 100 mg, plus tenofovir/emtricitabine, for the initial treatment of HIV infection: 48-week results of ALERT. AIDS Res Ther. 2008 Mar 28;5:5.
Common TitleAPV109141 Industry
Official Title Study of Once-Daily Versus Twice-Daily Fosamprenavir Plus Ritonavir, Administered With Abacavir/Lamivudine Once-Daily in Antiretroviral-Naive HIV-1 Infected Adult Subjects.
Phase Phase III
ClinicalTrials.gov NCT00450580
Treatments
Fosamprenavir
Fosamprenavir
Tradename:LexivaOther Names:FPVClass:Protease Inhibitors (PI)Categories Treatment-Naive
Funding
IndustryViiV Healthcare
References
- Carosi G, Lazzarin , Stellbrink H, et al. Study of once-daily versus twice-daily fosamprenavir plus ritonavir administered with abacavir/lamivudine once daily in antiretroviral-naïve HIV-1-infected adult subjects. HIV Clin Trials. 2009;10:356-67.
Common TitleAPV29005 Industry
Official Title A 48 Week, Phase II, non-comparative, open-label, multi-cohort, multicenter study to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of fosamprenavir (GW433908)/Ritonavir BID when administered to HIV-1 infected PI-Naive and experienced, Pediatric Subjects 2 to 18 years old and of fosamprenavir (GW433908) BID Administered to PI-Naive Pediatric subjects 2 to <6 years old
Phase Phase II
ClinicalTrials.gov NCT00089583
Treatments
Fosamprenavir
Fosamprenavir
Tradename:LexivaOther Names:FPVClass:Protease Inhibitors (PI)Categories PediatricsTreatment-Experienced
Funding
IndustryViiV Healthcare
References
- Fortuny C, Duiculescu D, Cheng K, et al. Pharmacokinetics and 48-week safety and antiviral activity of fosamprenavir-containing regimens in HIV-infected 2- to 18-year-old children. Pediatr Infect Dis J. 2014;33:50-6.
Common TitleAPV30005 Industry
Official Title An Open-Label Phase III Study to Assess the Long Term Safety Profile of Fosamprenavir (GW433908) Containing Regimens in HIV-1 Infected Subjects
Phase Phase III
ClinicalTrials.gov NCT00296504
Treatments
Fosamprenavir
Fosamprenavir
Tradename:LexivaOther Names:FPVClass:Protease Inhibitors (PI)Categories Treatment-NaivePharmacologyAdverse Effects
Funding
IndustryViiV Healthcare
References
- Gathe JC Jr, Wood R, Sanne I, et al. Long-term (120-Week) antiviral efficacy and tolerability of fosamprenavir/ritonavir once daily in therapy-naive patients with HIV-1 infection: an uncontrolled, open-label, single-arm follow-on study. Clin Ther. 2006;28:745-54.
- Wood R, Gathe JC, Givens N, Sedani S, Cheng K, Sievers J. Long-term safety study of fosamprenavir-containing regimens in HIV-1-infected patients. HIV Clin Trials. 2013;14:183-91.
Common TitleKLEAN Industry
Official Title A Phase IIIB, Randomized, Open-Label, Multicenter Study of the Safety and Efficacy of fosamprenavir (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
Phase Phase IIIB
ClinicalTrials.gov NCT00085943
Treatments
Lopinavir-Ritonavir
, Lopinavir-Ritonavir
Tradename:KaletraOther Names:LPV-RTVClass:Protease Inhibitors (PI)Fosamprenavir
, Fosamprenavir
Tradename:LexivaOther Names:FPVClass:Protease Inhibitors (PI)Ritonavir
Ritonavir
Tradename:NorvirOther Names:RTVClass:Pharmacokinetic EnhancersCategories Treatment-Naive
Funding
IndustryGlaxoSmithKline
References
- Eron J Jr, Yeni P, Gathe J Jr, et al. The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with abacavir-lamivudine, for initial treatment of HIV infection over 48 weeks: a randomised non-inferiority trial. Lancet. 2006;368:476-82.
- Pulido F, Estrada V, Baril JG, et al. Long-term efficacy and safety of fosamprenavir plus ritonavir versus lopinavir/ritonavir in combination with abacavir/lamivudine over 144 weeks. HIV Clin Trials. 2009;10:76-87.
Common TitleLESS Industry
Official Title 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)
Phase Phase IIIB
ClinicalTrials.gov NCT00363142
Treatments
Fosamprenavir
Fosamprenavir
Tradename:LexivaOther Names:FPVClass:Protease Inhibitors (PI)Categories Treatment-Experienced
Funding
IndustryGlaxoSmithKline
References
- Cohen C, Dejesus E, Lamarca A, et al. Similar virologic and immunologic efficacy with fosamprenavir boosted with 100 mg or 200 mg of ritonavir in HIV-infected patients: results of the LESS trial. HIV Clin Trials. 2010;11:239-47.
Common TitleNEAT Industry
Official Title A Phase III, Randomised, Multicenter, Parallel, Open-Label Study to Compare the Efficacy, Safety, and Tolerability of Fosamprenavir (GW433908) (1400 Mg Bid) and Nelfinavir (1250 Mg Bid) Over 48 Weeks in Antiretroviral Therapy Naive HIV-1 Infected Adults
Phase Phase III
ClinicalTrials.gov NCT00008554
Treatments
Fosamprenavir
, Fosamprenavir
Tradename:LexivaOther Names:FPVClass:Protease Inhibitors (PI)Nelfinavir
Nelfinavir
Tradename:ViraceptOther Names:NFVClass:Protease Inhibitors (PI)Categories Treatment-Naive
Funding
IndustryGlaxo Wellcome
References
- Rodriguez-French A, Boghossian J, Gray GE, et al. The NEAT study: a 48-week open-label study to compare the antiviral efficacy and safety of GW433908 versus nelfinavir in antiretroviral therapy-naive HIV-1-infected patients. J Acquir Immune Defic Syndr. 2004;35:22-32.
Common TitleSOLO Industry
Official Title A Randomized, Open-Label, Two Arm Trial to Compare the Safety and Antiviral Efficacy of Fosamprenavir (GW433908)/Ritonavir QD to Nelfinavir BID When Used in Combination With Abacavir and Lamivudine for 48 Weeks in Antiretroviral Therapy Naive HIV-1 Infected Subjects
Phase Phase III
ClinicalTrials.gov NCT00009061
Treatments
Fosamprenavir
, Fosamprenavir
Tradename:LexivaOther Names:FPVClass:Protease Inhibitors (PI)Nelfinavir
, Nelfinavir
Tradename:ViraceptOther Names:NFVClass:Protease Inhibitors (PI)Ritonavir
Ritonavir
Tradename:NorvirOther Names:RTVClass:Pharmacokinetic EnhancersCategories Treatment-Naive
Funding
IndustryGlaxo Wellcome
References
- Gathe JC Jr, Ive P, Wood R, et al. SOLO: 48-week efficacy and safety comparison of once-daily fosamprenavir /ritonavir versus twice-daily nelfinavir in naive HIV-1-infected patients. AIDS. 2004;18:1529-37.
- Gathe JC Jr, Wood R, Sanne I, et al. Long-term (120-Week) antiviral efficacy and tolerability of fosamprenavir/ritonavir once daily in therapy-naive patients with HIV-1 infection: an uncontrolled, open-label, single-arm follow-on study. Clin Ther. 2006;28:745-54.
Official Title A Study in Underrepresented Patient Population or Regimen Tolerability: SUPPoRT
Phase Phase III
ClinicalTrials.gov NCT00727597
Treatments
Fosamprenavir
, Fosamprenavir
Tradename:LexivaOther Names:FPVClass:Protease Inhibitors (PI)Efavirenz
Efavirenz
Tradename:SustivaOther Names:EFVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories PharmacologyTreatment-NaiveAdverse Effects
Funding
Non-IndustryGeorgetown University
References
- Kumar P, DeJesus E, Huhn G, et al. Evaluation of cardiovascular biomarkers in a randomized trial of fosamprenavir/ritonavir vs. efavirenz with abacavir/lamivudine in underrepresented, antiretroviral-naïve, HIV-infected patients (SUPPORT): 96-week results. BMC Infect Dis. 2013;13:269.
Common TitleTRIAD Industry
Official Title 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
Phase Phase III
ClinicalTrials.gov NCT00144833
Treatments
Fosamprenavir
Fosamprenavir
Tradename:LexivaOther Names:FPVClass:Protease Inhibitors (PI)Categories Resistance/Virological FailureTreatment-Experienced
Funding
IndustryGlaxoSmithKline
References
- Molina JM, Ait-Khaled M, Rinaldi R, et al. 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. J Antimicrob Chemother. 2009;64:398-410.
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SUPPORT - February 24, 2020