AIDSWEEKLY Plus; Monday, July 20, 2009
Staff Medical Writers

(NewsRx.com) -- "The KLEAN study extension assessed the long-term efficacy and safety of fosamprenavir-ritonavir (FPV/r) and lopinavir-ritonavir (LPV/r), both administered with abacavir/lamivudine (ABC/3TC) fixed dose combination, over 144 weeks. KLEAN was an open-label, noninferiority study that randomised anti retroviral-naive patients to FPV/r twice daily (bid) or LPV/r bid with ABC/3TC once daily (qd)," researchers in the United Kingdom report (see also HIV/AIDS).

"Patients with a viral load of < 400 copies/mL at Week 48 were eligible to participate in the KLEAN study extension (up to 144 weeks) and continued with their previously randomised therapy. The KLEAN study extension (48 to 144 weeks) randomized 199 patients. The proportion of TLOVR responders (HIV-1 RNA < 50 copies/mL) at Week 144 was 73% and 60% in the FPV/r and LPV/r arms, respectively. The proportion of TLOVR responders (< 50 copies/mL) was the same irrespective of baseline HIV-1 RNA (>100,000 or ≤100,000 copies/mL). The Week 144 median (interquartile range) change from baseline CD4+ cell count was 300 (236-433) cells/mm(3) and 335 (225-444) cells/mm(3) in the FPV/r and LPV/r arms, respectively. Diarrhea was the most frequently reported adverse event. A small proportion of patients (FPV/r, 13%; LPV/r, 9%) discontinued study medication due to adverse events. Three patients (FPV/r, 1; LPV/r, 2) experienced virological failure between Week 48 and Week 144. The findings of the KLEAN study extension (48 to 144 weeks) support durable viral suppression with both FPV/r and LPV/r treatment regimens when used in combination with ABC/3TC irrespective of viral load at baseline," wrote F. Pulido and colleagues, GlaxoSmithKline.

The researchers concluded: "Both regimens were well tolerated and had similar safety profiles.."

Pulido and colleagues published their study in HIV Clinical Trials (Long-Term Efficacy and Safety of Fosamprenavir plus Ritonavir Versus Lopinavir/Ritonavir in Combination with Abacavir/Lamivudine over 144 Weeks. HIV Clinical Trials, 2009;10(2):76-87).

For additional information, contact C. Pharo, GlaxoSmithKline Pharma Europe, HIV Center Excellence, CS2-143, GSK House, 980 Great W Rd., Brentford TW8 9GS, UK.

Publisher contact information for the journal HIV Clinical Trials is: Thomas Land Publishers, Inc., 255 Jefferson Rd., St. Louis, MO 63119, USA.

Keywords: United Kingdom, HIV/AIDS, AIDS, Abacavir, Acquired Immunodeficiency Syndrome, Anti-Infectives, Antivirals, Clinical Trial Research, Drugs, GlaxoSmithKline, HIV, Human Immunodeficiency Virus, Lamivudine, Nucleoside Reverse Transcriptase Inhibitor, Pharmaceutical Business, Pharmaceutical Company, Pharmaceuticals, Protease Inhibitor, Ritonavir, Therapy, Treatment, Viral Load, Virology, GlaxoSmithKline.

This article was prepared by AIDS Weekly editors from staff and other reports.

Ref: Pulido F, Estrada V, Baril JG, et al. “Long-term efficacy and safety of fosamprenavir plus ritonavir versus lopinavir/ritonavir in combination with abacavir/lamivudine over 144 weeks”, HIV Clin Trials. 2009 Mar-Apr;10(2):76-87.

2009-07-20
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