A randomized study investigating the efficacy and safety of amprenavir in combination with low-dose ritonavir in protease inhibitor-experienced HIV-infected adults

HIV Medicine
F PulidoP Tymkewycz

Abstract

To compare the safety and efficacy of amprenavir [APV/j Agenerase trade mark; GlaxoSmithKline, [Ware, UK; 600 mg twice a day (bid)] boosted with low-dose ritonavir (RTV, 100 mg bid) with those of other protease inhibitors (PIs) in PI-experienced HIV-infected patients. Parallel-group, randomized, open-label, multicentre study. One hundred and sixty-three patients with HIV predicted to be sensitive to APV, another PI and a nucleoside reverse transcriptase inhibitor (NRTI) were randomly assigned to receive either APV boosted with low-dose RTV (APV/r) or a standard of care (SOC) PI with or without low-dose RTV. The non-inferiority of APV/r to the SOC PIs was assessed by time-weighted average change from baseline (AAUCMB) in plasma viral load (vRNA) at week 16. The antiviral response for APV/r bid was non-inferior to that for the SOC PI group: the vRNA AAUCMB mean treatment difference was 0.043 log(10) HIV-1 RNA copies/mL [95% confidence interval (CI)-0.250, 0.335]. APV/r bid was generally well tolerated. Results confirm the antiviral activity, short-term safety and tolerability of APV/r bid in PI-experienced patients.

References

Aug 3, 2002·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Laura RomanoMaurizio Zazzi
Feb 7, 2003·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Yvonne C GilleeceMark R Nelson

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Citations

Aug 11, 2001·The New England Journal of Medicine·J S Montaner, J W Mellors
Feb 21, 2006·Clinical Pharmacokinetics·Mary Beth WireScott Studenberg
Oct 20, 2006·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Joseph GatheUNKNOWN RESIST-1 Study Group
May 14, 2008·HIV Clinical Trials·Ann C CollierUNKNOWN AIDS Clinical Trials Group Protocol A5143 Team
Oct 23, 2013·HIV Clinical Trials·Robin WoodJörg Sievers
Mar 12, 2019·Frontiers in Microbiology·Karin KosulinThomas Lion

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