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15 November 2006

Volume 43, Number 10
Clinical Infectious Diseases 2006;43:1347–1356
© 2006 by the Infectious Diseases Society of America. All rights reserved.
1058-4838/2006/4310-0020$15.00
DOI: 10.1086/508352
HIV/AIDS MAJOR ARTICLE

Ritonavir‐Boosted Tipranavir Demonstrates Superior Efficacy to Ritonavir‐Boosted Protease Inhibitors in Treatment‐Experienced HIV‐Infected Patients: 24‐Week Results of the RESIST‐2 Trial

Pedro Cahn,1

Jorge Villacian,5

Adriano Lazzarin,8

Christine Katlama,9

Beatriz Grinsztejn,2

Keikawus Arasteh,7

Paulo López,3

Nathan Clumeck,10

Jan Gerstoft,11

Nikolas Stavrianeas,12

Santiago Moreno,13

Francisco Antunes,14

Dietmar Neubacher,6 and

Douglas Mayers4

1Fundación Huésped, Buenos Aires, Argentina; 2Fundação Oswaldo Cruz, Rio de Janeiro, Brazil; 3Hospital Juan I Menchaca, Instituto Mexicano del Seguro Social, Guadalajara‐Jalisco, Mexico; 4Boehringer Ingelheim Pharmaceuticals, Ridgefield, Connecticut; 5Boehringer Ingelheim GmbH, Germany, 6Boehringer Ingelheim GmbH and Co. KG, Ingelheim, and 7Auguste‐Viktoria Klinikum, Berlin, Germany; 8Vila‐Salute San Raffaele University, Milan, Italy; 9Hôpital de la Pitié‐Salpétrière, Paris, France; 10Hôpital Universitaire St. Pierre, Bruxelles, Belgium; 11Rigshospitalet, Copenhagen, Denmark; 12Andreas Syngros Hospital, Athens, Greece; 13Hospital Ramón y Cajal, Madrid, Spain; and 14Hospital de Santa Maria, Lisbon, Portugal

Background.Tipranavir, a novel protease inhibitor, has demonstrated antiviral activity against protease inhibitor–resistant human immunodeficiency virus type 1 (HIV‐1) isolates. The Randomized Evaluation of Strategic Intervention in multi‐drug reSistant patients with Tipranavir (RESIST‐2) trial is an ongoing, open‐label, phase III trial comparing ritonavir‐boosted tipranavir (TPV/r) plus an optimized background regimen with an individually optimized, ritonavir‐boosted protease inhibitor in treatment‐experienced, HIV‐1–infected patients.

Methods.Patients at 171 sites in Europe and Latin America who had received 2 previous protease inhibitor regimens, had triple‐antiretroviral class experience, had an HIV‐1 RNA level 1000 copies/mL, and had genotypically demonstrated primary protease inhibitor resistance were eligible. After genotypic resistance tests were performed, a protease inhibitor and optimized background regimen were selected before randomization. Patients were randomized to receive either TPV/r or comparator protease inhibitor–ritonavir (CPI/r) and were stratified on the basis of preselected protease inhibitor and enfuvirtide use. Treatment response was defined as a confirmed HIV‐1 load reduction 1 log10 less than the baseline value without a treatment change at week 24.

Results.A total of 863 patients were randomized and treated. At baseline, the mean HIV‐1 load was 4.73 log10 copies/mL, and the mean CD4+ cell count was 218 cells/mm3. The preplanned 24‐week efficacy analyses of 539 patients demonstrated treatment response rates of 41% in the TPV/r arm and 14.9% in the CPI/r arm (intent‐to‐treat analysis; ). The mean CD4+ cell count increased by 51 cells/mm3 in the TPV/r arm and by 18 cells/mm3 in the CPI/r arm. The most common adverse events were mild‐to‐moderate diarrhea, nausea, and headache. Grade 3 or greater elevations in serum transaminase, cholesterol, and triglyceride levels were more frequent in the TPV/r arm.

Conclusions.TPV/r had superior antiviral activity and increased immunologic benefits, compared with CPI/r, at week 24 among treatment‐experienced patients infected with multidrug‐resistant HIV‐1.

Received 20 February 2006; accepted 31 July 2006; electronically published 17 October 2006.

Reprints or correspondence: Dr. Pedro Cahn, Fundación Huésped, Angel Peluffo 3932, Buenos Aires, Argentina ().

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