Antiviral activity and safety of aplaviroc, a CCR5 antagonist, in combination with lopinavir/ritonavir in HIV-infected, therapy-naïve patients: results of the EPIC study (CCR100136)
| Autor: | P, Yeni, A, Lamarca, D, Berger, P, Cimoch, A, Lazzarin, P, Salvato, F M, Smaill, E, Teofilo, S J, Madison, W G, Nichols, K K, Adkison, T, Bonny, J, Millard, D, McCarty, Thomas T, Jefferson |
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| Rok vydání: | 2009 |
| Předmět: |
Adult
Male Receptors CCR5 Aplaviroc Population Lopinavir/ritonavir HIV Infections Diketopiperazines Pyrimidinones CCR5 receptor antagonist Pharmacology Benzoates Drug Administration Schedule Lopinavir Piperazines Young Adult Zidovudine immune system diseases medicine Humans Spiro Compounds Pharmacology (medical) education neoplasms Aged education.field_of_study Ritonavir business.industry Health Policy Lamivudine HIV Protease Inhibitors Middle Aged Infectious Diseases HIV-1 RNA Viral Drug Therapy Combination Female business medicine.drug |
| Zdroj: | HIV Medicine. 10:116-124 |
| ISSN: | 1468-1293 1464-2662 |
| DOI: | 10.1111/j.1468-1293.2008.00660.x |
| Popis: | Background This phase IIb study explored the antiviral activity and safety of the investigational CC chemokine receptor 5 (CCR5) antagonist aplaviroc (APL) in antiretroviral-naive patients harbouring R5- or R5X4-tropic virus. Methods A total of 191 patients were randomized 2:2:2:1 to one of three APL dosing regimens or to lamivudine (3TC)/zidovudine (ZDV) twice daily (bid), each in combination with lopinavir/ritonavir (LPV/r) 400 mg/100 mg bid. Efficacy, safety and pharmacokinetic parameters were assessed. Results This study was terminated prematurely because of APL-associated idiosyncratic hepatotoxicity. A total of 141 patients initiated treatment early enough to have been able to complete 12 weeks on treatment [modified intent-to-treat (M-ITT) population]; of these, 133 completed the 12-week treatment phase. The proportion of subjects in the M-ITT population with HIV-1 RNA |
| Databáze: | OpenAIRE |
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