Durability of response to treatment among antiretroviral-experienced subjects: 48-week results from AIDS Clinical Trials Group Protocol 359.

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 <or=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.

• Authors: Roy M Gulick, X Joan Hu, Susan A Fiscus, Courtney V Fletcher, Richard Haubrich, Hailong Cheng, Edward Acosta, Stephen W Lagakos, Ronald Swanstrom, William Freimuth, Sally Snyder, Charlotte Mills, Margaret Fischl, Carla Pettinelli, David Katzenstein
• Journal: The Journal of infectious diseases (J Infect Dis) Vol. 186 Issue 5 Pg. 626-33 (Sep 01 2002) ISSN: 0022-1899 [Print] United States
• PMID: 12195349 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Antiviral Agents
• HIV Protease Inhibitors
• RNA, Viral
• Reverse Transcriptase Inhibitors
• Delavirdine
• Saquinavir
• Ritonavir

Topics

• Antiviral Agents (therapeutic use)
• CD4 Lymphocyte Count
• Delavirdine (therapeutic use)
• Double-Blind Method
• Drug Therapy, Combination
• HIV
• HIV Infections (drug therapy, metabolism, virology)
• HIV Protease Inhibitors (therapeutic use)
• Humans
• Prospective Studies
• RNA, Viral (blood)
• Reverse Transcriptase Inhibitors (therapeutic use)
• Ritonavir (therapeutic use)
• Salvage Therapy
• Saquinavir (therapeutic use)