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A randomized study investigating the efficacy and safety of amprenavir in combination with low‐dose ritonavir in protease inhibitor‐experienced HIV‐infected adults
Author(s) -
Pulido F,
Katlama C,
Marquez M,
Thomas R,
Clumeck N,
De J Pedro R,
Cattelan AM,
Zhu C,
Tymkewycz P
Publication year - 2004
Publication title -
hiv medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 79
eISSN - 1468-1293
pISSN - 1464-2662
DOI - 10.1111/j.1468-1293.2004.00224.x
Subject(s) - amprenavir , medicine , ritonavir , tolerability , darunavir , confidence interval , randomized controlled trial , viral load , adverse effect , protease inhibitor (pharmacology) , pharmacology , reverse transcriptase inhibitor , nucleoside reverse transcriptase inhibitor , virology , gastroenterology , protease , human immunodeficiency virus (hiv) , antiretroviral therapy , hiv 1 protease , enzyme , chemistry , biochemistry
Objectives To compare the safety and efficacy of amprenavir [APV/j Agenerase™; 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. Study design Parallel‐group, randomized, open‐label, multicentre study. Methods 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. Results 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. Conclusions Results confirm the antiviral activity, short‐term safety and tolerability of APV/r bid in PI‐experienced patients.