Abstract: Kaletra vs. Nelfinavir in Antiretroviral-Naive Subjects: Week 60 Comparison in a Phase III, Blinded, Randomized Clinical Trial

Medical Advocates for Social Justice
Conference Abstract

1st International AIDS Society Conference on HIV Pathogenesis and Treatment. Buenos Aires, Argentina -
July 8 - July 11, 2001

Kaletra vs. Nelfinavir in Antiretroviral-Naïve Subjects: Week 60 Comparison in a Phase III, Blinded, Randomized Clinical Trial. P. Ruane¹, J. Mendonca², A. Timerman³, P. Cernohous⁴, E. Bauer⁴, B. Bernstein⁴, and E. Sun.⁴

¹Tower ID of Los Angeles, ²Hospital do Servidor Publico Estadual de São Paulo, ³Secretaria de Estado de Saude for Hospital Heliópolis - São Paulo, ⁴Abbott Laboratories, Abbott Park, IL

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Background. Kaletra is a coformulation of lopinavir (LPV), an HIV protease inhibitor, and ritonavir (r), which inhibits CYP3A, providing increased plasma levels of LPV.

Methods. Study M98-863 is a multi-center, international, double-blind randomized study of 653 (129 female) ARV-naïve subjects treated with either LPV/r 400/100 mg BID +d4T/3TC (N=326) or NFV 750 mg TID +d4T/3TC (N=327). Mean baseline HIV RNA level and CD4 cell count were 4.9 log₁₀ copies/mL and 259 cells/mL.

Results. At Week 60, in an intent-to-treat analysis (noncompleter=failure), a statistically significantly higher proportion of LPV/r-treated subjects than NFV-treated subjects achieved HIV RNA <400 copies/mL (74% vs. 61%, p<0.001) or <50 copies/mL (63% vs. 51%, p=0.001). The mean increase from baseline to Week 60 in CD4 cell count was 246 cells/mL for the LPV/r group and 224 cells/mL for the NFV group (p=0.128). Subjects on the LPV/r arm with baseline CD4 cell counts <50 cells/mL had a statistically significantly greater mean change from baseline to Week 60 in CD4 (+268 vs. +194 cells/mL, p=0.006). AEs occurring in >2% of subjects included diarrhea, nausea, asthenia, abdominal pain, vomiting, and headache. Through Week 60, 4% of subjects in each treatment group discontinued due to PI-related AEs. The most common laboratory abnormalities were triglyceride and cholesterol elevations. No subject reported an AE of lipid elevation that led to study discontinuation. Viral isolates from subjects with HIV RNA >400 copies/mL at any visit from Week 24 through Week 48 were analyzed for evidence of PI resistance. 0/37 (0%) LPV/r-treated subjects and 25/76 (33%) NFV-treated subjects demonstrated genotypic resistance in protease (p<0.001).

Conclusions. A significantly greater proportion of LPV/r-treated subjects achieved HIV RNA <400 copies/mL and <50 copies/mL at Week 60. Both regimens were well tolerated, as manifested by the low incidence of study drug-related discontinuations through Week 60.

Abstract provided by Abbott Laboratories

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Abstract
Kaletra vs. Nelfinavir in Antiretroviral-Naive Subjects:
Week 60 Comparison in a Phase III, Blinded, Randomized Clinical Trial