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Original Articles

Long-Term Safety Study of Fosamprenavir-Containing Regimens in HIV-1–Infected Patients

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Pages 183-191 | Published online: 22 Dec 2014

REFERENCES

  • Mocroff A, Ledergerber B, Katlama C, et al; for the Euro-SIDA Study Group. Decline in the AIDS and death rates in the EuroSIDA study: An observational study. Lancet. 2003;362:22–29.
  • Schneider MF, Gange SJ, Williams CM, et al. Patterns of the hazard of death after AIDS through the evolution of antiretroviral therapy: 1984-2004. AIDS. 2005;19:2009–2018.
  • Gandhi T, Wei W, Amin K, Kazanjian P. Effect of maintaining highly active antiretroviral therapy on AIDS events among patients with late stage HIV infection and inadequate response to therapy. Clin Infect Dis. 2006;42:878–884.
  • Gandhi T, Nagappan V, Cinti S, et al. Long-term immu-nologic and virologic responses in patients with highly resistant HIV infection who are treated with an incom-pletely suppressive antiretroviral regimen. Clin Infect Dis. 2007;45:1085–1092.
  • Kousignian I, Abgrall S, Grabar S, et al. Maintaining anti-retroviral therapy reduces the risk of AIDS-defining events in patients with uncontrolled viral replication and profound immunodeficiency. Clin Infect Dis. 2008;46:296–304.
  • US Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents - A Working Group of the Office of AIDS Research Advisory Council. Guidelines for the use of antiretroviral agents in HIV-1 infected adults and adolescents. February 12, 2013. http://aidsinfo.nih.gov/contentfiles/Ivguidelines/adultand-adolescentgl.pdf. Accessed March 14, 2013.
  • European AIDS Clinical Society (EACS) guidelines for treatment of HIV-infected adults in Europe. November 2012. http://www.europeanaidsclinicalsociety.org/images/stories/EACS-Pdf/EacsGuidelines-v6.1-2edition.pdf. Accessed March 14, 2013.
  • 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.
  • Gathe JC Jr, Lye P, Wood R, et al. SOLO: 48-week efficacy and safety comparison of once-daily fosamprenavir /rito-navir versus twice-daily nelfinavir in naive HIV-1-infected patients. AIDS. 2004;18:1529–1537.
  • DeJesus E, Lamarca A, Sension M, et al. The Context Study: Efficacy and safety of GW433908/RTV in P1-expe-rienced subjects with virological failure (24 week results). Presented at: 10th Conference of Retroviruses and Oppor-tunistic Infections; February 10–14, 2003; Boston, MA, USA. Abstract 178.
  • Wood R, Arasteh K, Stellbrink HJ, et al. Six-week random-ized controlled trial to compare the tolerabilities, pharma-cokinetics, and antiviral activities of FPV and amprenavir in human immunodeficiency virus type 1-infected patients. Antimicrob Agents Chemother. 2004;48:116–123.
  • GSK Clinical Study Register. AZL30006: A phase Illb/ IV, randomized, open label, multicenter, pilot trial to explore the safety and tolerability of GW433908 +/- rito-navir (1400 mg twice daily or 700 mg/100 mg 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 sub-jects. www.gsk-clinicalstudyregister.com. Accessed August 7, 2013.
  • Sosa N, Hill-Zabala C, Dejesus E, et al. Abacavir and lamivudine fixed-dose combination tablet once daily compared with abacavir and lamivudine twice daily in HIV-infected patients over 48 weeks (E5530008, SEAL). J Acquir Immune Defic Syndr. 2005;40:422–427.
  • Bartlett JA, Johnson J, Herrera G, et al. Long-term results of initial therapy with abacavir and lamivudine combined with efavirenz, amprenavir/ritonavir, or stavudine. J Acquir Immune Defic Syndr. 2006;43:284–292.
  • Pulido F, Katlama C, Marquez M, et al. A randomized study investigating the efficacy and safety of amprenavir in com-bination with low-dose ritonavir in protease inhibitor-expe-rienced HIV-infected adults. HIV Med. 2004;5:296–302.
  • GSK Clinical Study Register. PROAB3007: An open-label phase III study to assess the long term safety profile of amprenavir (141W94) containing regimens in HIV infected subjects. www.gsk-clinicalstudyregister.com. Accessed August 7, 2013.
  • Eron JJ Jr, Park JG, Haubrich R, et al; ACTG5126 Study Team. Predictive value of pharmacokinetics-adjusted phe-notypic susceptibility on response to ritonavir-enhanced protease inhibitors (Pis) in human immunodeficiency virus-infected subjects failing prior PI therapy. Antimicrob Agents Chemother. 2009;53:2335–2341.
  • Centers for Disease Control and Prevention. 1993 Revised classification system for HIV infection and expanded sur-veillance case definition for AIDS among adolescents and adults. MMWR Recomm Rep. 1992;41:1–19.
  • Division of AIDS, National Institute of Allergy and Infec-tious Diseases. Table for Grading Severity of Adult Adverse Experiences. Rockville, MD: NIAID; 1992.
  • Division of AIDS, National Institute of Allergy and Infec-tious Diseases. Table for Grading Severity of Adult Adverse Experiences. Rockville, MD: NIAID; 2004.
  • Gathe JC Jr, Wood R, Sanne I, et al. Long-term (120-week) antiviral efficacy and tolerability of fosamprenavir/ritonavir once daily in therapy-naïve patients with HIV-1 infection: An uncontrolled, open-label, single-arm follow-on study. Clin Ther. 2006;28:745–754.
  • Bellos N, Clumeck N, Bleiber G, et al. Sustained virologic and immunologic response over 180 weeks in antiretroviral therapy (ART)-naïve subjects receiving fosamprenavir/ ritonavir (FPV/RTV) QD. Presented at: 8th International Congress on Drug Therapy in HIV Infection; November 12–16, 2006; Glasgow, UK. Abstract P13.
  • Friis-Møller N, Reiss P, Sabin CA, et al; DAD Study Group. Class of antiretroviral drugs and the risk of myocardial infarction. N Engl J Med. 2007;356:1723–1735.
  • Lang S, Mary-Krause M, Cotte L, et al. Impact of individual antiretroviral drugs on the risk of myocardial infarction in human immunodeficiency virus-infected patients: A case-control study nested within the French Hospital Database on HIV ANRS cohort CO4. Arch Intern Med. 2010;170:1228–1238.
  • Murphy RL, da Silva B, Hicks CB, et al. Seven-year effi-cacy of a lopinavir/ritonavir-based regimen in antiretroviral-naive HIV-1-infected patients. HIV Clin Trials. 2008;9:1–10.
  • 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-inferior-ity trial. Lancet. 2006;368:476–482.
  • Pulido F, Estrada V, Bari 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.

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