DANNER S, BRUN S, SYLTE J, ISAACSON J, LAZZARIN A, GIRARD PM, ROCKSTROH J, BECKER S, PANTALEO G, BERGMANN F, CLUMECK N, HO D, TUBIANA R, CAROSI G, BERTZ R, HSU A, KING M, RICHARDS B, KEMPF D, SUN E; Interscience Conference on Antimicrobial Agents and Chemotherapy (41st : 2001 : Chicago, Ill.).

Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 2001 Dec 16-19; 41: abstract no. I-1925.

Academic Med. Ctr. Amsterdam, Amsterdam, The Netherlands

BACKGROUND: Kaletra (LPV/r) is an HIV protease inhibitor (PI) with mean trough concentrations that well exceed its protein binding corrected IC[50] for wild type HIV when dosed at 400/100 mg BID. METHODS: Multiple PI experienced/NNRTI naive patients (n=57) with viral load (VL) >1000 c/mL on therapy were randomized to Kaletra at either 400/100(3capsules) or 533/133 mg (4 capsules) BID with EFV 600 mg QD and NRTIs. After 24 weeks, all patients began open label 533/133 mg BID dosing. Results. At Week 72 by ITT (M=F) analysis, VL was <400 copies/mL in 67% (OT: 88%) of patients. In a dropouts as censored (DAC) analysis at Week 72, 93%, 73%, and 25% of patients with baseline reduced susceptibility to LPV (vs. wild-type) of <10-fold, 10- to 40-fold, or >40-fold had VL <400 copies/mL, as did 91%, 71%, and 33% of patients with baseline LPV mutation scores of 0-5, 6-7, and 8-10. Mean increase from BL to Week 72 in CD4 cell count was 125 cells/mm[3]. The most common LPV/r-related AEs were diarrhea and asthenia, and lipid elevations were the most common lab abnormalities. Through Week 72, 13 patients prematurely discontinued, including 4 for LPV/r-related AEs and 5 for virologic failure. CONCLUSION: Kaletra and EFV are well tolerated and exhibit antiretroviral effect in multiple PI experienced patients through 72 weeks of treatment.

Publication Types:

• Meeting Abstracts

Keywords:

• Anti-HIV Agents
• CD4 Lymphocyte Count
• HIV
• HIV Infections
• HIV Protease
• HIV Protease Inhibitors
• Humans
• Oxazines
• Pyrimidinones
• Ritonavir
• Viral Load
• efavirenz
• lopinavir
• methods

Other ID:

• GWAIDS0029069

UI: 102268701

From Meeting Abstracts