Antiviral activity and safety of aplaviroc with lamivudine/zidovudine in HIV-infected, therapy-naive patients: The ASCENT (CCR102881) study

Judith Currier, Adriano Lazzarin, Louis Sloan, Nathan Clumeck, Jihad Slim, Deb McCarty, Helen Steel, Jörg Peter Kleim, Tab Bonny, Judith Millard

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Abstract

Background: This Phase lib study explored the antiviral activity and safety of the investigational CCR5 antagonist aplaviroc (APL) in antiretroviral-naive patients harbouring R5-tropic virus. Methods: One hundred and forty-seven patients were randomized 2:2:1 to one of two APL dosing regimens or efavirenz (EFV). All dosage arms were administered twice daily and in combination with lamivudine/zidovudine (3TC/ZDV; Combivir, COM). Efficacy, safety, and pharmacokinetic parameters were assessed. Results: This study was prematurely terminated due to APL-associated idiosyncratic hepatotoxicity. The primary endpoint of the study was the proportion of patients with plasma HIV-1 RNA

Original languageEnglish
Pages (from-to)297-306
Number of pages10
JournalAntiviral Therapy
Volume13
Issue number2
Publication statusPublished - 2008

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ASJC Scopus subject areas

  • Pharmacology

Cite this

Currier, J., Lazzarin, A., Sloan, L., Clumeck, N., Slim, J., McCarty, D., Steel, H., Kleim, J. P., Bonny, T., & Millard, J. (2008). Antiviral activity and safety of aplaviroc with lamivudine/zidovudine in HIV-infected, therapy-naive patients: The ASCENT (CCR102881) study. Antiviral Therapy, 13(2), 297-306.