1. Durability of Response to Treatment among Antiretroviral‐Experienced Subjects: 48‐Week Results from AIDS Clinical Trials Group Protocol 359
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Jon Cook, Charles B. Hicks, Bruce Coon, Richard Hutt, Margaret A. Fischl, David Pearson, Jan Clark, Candida T. Talabucon, Carol L. Brosgart, Joan Dragavon, Laura Ponticello, Janet Devine, Eugene Sun, Melissa Kerkau, Daniel C. Rodrigue, Donna Thee, Jeanne Berg, Mario Guerrero, Lyle Oshita, Jane L. Norris, Judy Aberg, Mark I. Becker, John Fuchs, Pablo Tebas, Guillermo J. Vázquez, Pamposh Kaul, Antoinette Kenton, Phyllis Barnett, Pascal J. de Caprariis, Michael Royal, Michelle Jack, Ann Walawander, Harold A. Kessler, Scott Souza, Sharon Shriver, Genice Hamilton, Susan E. Cohn, Hailong Cheng, John G. Gerber, Monica Millard, Sherree Wright, Linh Ngo, Gildon N. Beall, Debra Ogata-Arakaki, John Mc Neil, David M. Mushatt, Courtney V. Fletcher, Charles van der Horst, Karen Waterman, Ileana Lopez, David Katzenstein, Robert J. Fass, Joseph J. Eron, Edward P. Acosta, Stephen W. Lagakos, Hilda Mendoza, Jim Bruce, Michael F. Para, Sally Snyder, Mary Shoemaker, Mark A. Beilke, Tammy Powell, Margaret Nelson, Juan J.L. Lertora, Liliana Aguinada, Virginia Ramirez, M. Graham Ray, William W. Freimuth, Brenda Greenhill, Beverly Putnam, Aouie Carrera, Mary Albrecht, Michael F. Giordano, Stuart Carr, John M. Leedom, Charlotte Mills, Charles J. Gonzalez, Rebecca Becker, Richard Haubrich, Elizabeth Gimbel, D. Baker, Vivian Yuan, Andrea Weiss, Hongyu Jiang, Cheryl N. Karol, Kim Ingersol, Russell Strada, Paulette Mac Dougall, Carla Pettinelli, Glenna M. Auerback, Alice F. Mercado, Frances Canchola, Chris Helker, Susan A. Fiscus, X. Joan Hu, Janine R. Maenza, Henry S. Sacks, Robert Kalajian, Debbie Slamowitz, Robin Shepard, Margo Heath-Chiozzi, Michael J. Borucki, Ana Martinez, Olivia T. Ortiz, Suzanne Fiorillo, Jorge Santana, Michael S. Saag, Dena Duran, Steve Nowling, Jeff Taylor, Kristine Todd, Robert W. Coombs, Douglas D. Richman, Thomas C. Merigan, Robert Delapenha, Kenneth Wood, Harvey M. Friedman, Joseph Pulvirenti, Don Craven, Timothy W. Schacker, Ronald Swanstrom, Neel French, Judith Feinberg, Mark A. Jacobson, Judith Brown, Joseph Wheat, Ross G. Hewitt, James F. Rooney, Scott A. Smith, Bruce Peel, Doris Shank, Lisa Alexis, Roy M. Gulick, Andrea Christopher Belschner, and Linda Meixner
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medicine.medical_specialty ,HIV Infections ,Antiviral Agents ,Double-Blind Method ,Acquired immunodeficiency syndrome (AIDS) ,Indinavir ,Internal medicine ,medicine ,Adefovir ,Humans ,Immunology and Allergy ,Delavirdine ,Prospective Studies ,Saquinavir ,Salvage Therapy ,Ritonavir ,Nucleoside analogue ,business.industry ,HIV ,HIV Protease Inhibitors ,medicine.disease ,CD4 Lymphocyte Count ,Surgery ,Infectious Diseases ,Nelfinavir ,RNA, Viral ,Reverse Transcriptase Inhibitors ,Drug Therapy, Combination ,business ,medicine.drug - Abstract
The 24-week extension of AIDS Clinical Trials Group Protocol 359, a study of human immunodeficiency virus (HIV)‐infected, indinavir-experienced patients, was designed to study the durability of “salvage” treatment regimens. Patients received saquinavir in combination with either ritonavir or nelfinavir and, in addition, delavirdine, adefovir, or both. Patients who demonstrated a virologic response at weeks 12‐16 were eligible to continue therapy in the extension through week 48. Of the 105 eligible subjects who were enrolled in the extension, 86 (82%) completed 48 weeks, and 49 (57%) of those 86 had HIV RNA levels 500 copies/ mL at week 48. For these 86 subjects who completed 48 weeks, the median change in CD4 cell count from baseline was +72 cells/mm 3 . Greater body weight, higher CD4 cell count, and greater degree of phenotypic susceptibility to indinavir and saquinavir at baseline were significantly associated with durable virologic suppression. These results show that some patients who experience treatment failure can demonstrate durable virologic and immunologic responses with salvage antiretroviral regimens. Current treatment guidelines recommend starting therapy for human immunodeficiency virus (HIV) infection with 2 nucleoside analogue reverse-transcriptase inhibitors in combination with 1 or 2 protease inhibitors or a nonnucleoside analogue reversetranscriptase inhibitor [1, 2]. However, 20%‐63% of patients from clinical cohorts experience virologic treatment failure while receiving combination antiretroviral therapy [3‐7]. Recent prospective studies have attempted to identify strategies for treatment of the treatment-experienced patient [8‐13], but these studies have focused primarily on 8‐24-week virologic responses to treatment. The durability of virologic and immunologic re
- Published
- 2002
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