Abstract:
OBJECTIVES: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. 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.
journal_name
HIV Medjournal_title
HIV medicineauthors
Pulido F,Katlama C,Marquez M,Thomas R,Clumeck N,Pedro Rde J,Cattelan AM,Zhu C,Tymkewycz Pdoi
10.1111/j.1468-1293.2004.00224.xkeywords:
subject
Has Abstractpub_date
2004-07-01 00:00:00pages
296-302issue
4eissn
1464-2662issn
1468-1293pii
HIV224journal_volume
5pub_type
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