title: Randomized study of saquinavir with ritonavir or nelfinavir together with delavirdine, adefovir, or both in human immunodeficiency virus-infected adults with virologic failure on indinavir: AIDS Clinical Trials Group Study 359.
abstract: This study compared antiretroviral activity among 6 "salvage" therapy regimens. The study was a prospective, randomized, 2x3 factorial, multicenter study of the AIDS Clinical Trials Group. The study enrolled 277 human immunodeficiency virus (HIV)-infected patients naive to nonnucleoside analogues who had taken indinavir >6 months. The patients had 2000-200,000 HIV RNA copies/mL. Patients received saquinavir with ritonavir or nelfinavir together with delavirdine and/or adefovir and were followed for safety and antiretroviral response between baseline and week 16. At week 16, 30% (77/254) of patients had </=500 HIV RNA copies/mL. Virologic response did not differ significantly between pooled ritonavir and nelfinavir groups (28% vs. 33%; P=.50) or between pooled delavirdine and delavirdine/adefovir groups (40% vs. 33%; P=.42). Pooled delavirdine groups had a greater virologic response rate than did adefovir groups (40% vs. 18%; P=.002). Overall, one-third of patients who experienced virologic failure on an indinavir-containing regimen suppressed virus load levels while they were taking a new salvage regimen.
authors.affiliation: Cornell Clinical Trials Unit, Division of International Medicine and Infectious Diseases, Dept. of Medicine, Weill Medical College of Cornell University, New York, NY 10021, USA. rgulick@med.cornell.edu
authors.forename: R M
authors.initials: RM
authors.lastname: Gulick
authors.forename: X J
authors.initials: XJ
authors.lastname: Hu
authors.forename: S A
authors.initials: SA
authors.lastname: Fiscus
authors.forename: C V
authors.initials: CV
authors.lastname: Fletcher
authors.forename: R
authors.initials: R
authors.lastname: Haubrich
authors.forename: H
authors.initials: H
authors.lastname: Cheng
authors.forename: E
authors.initials: E
authors.lastname: Acosta
authors.forename: S W
authors.initials: SW
authors.lastname: Lagakos
authors.forename: R
authors.initials: R
authors.lastname: Swanstrom
authors.forename: W
authors.initials: W
authors.lastname: Freimuth
authors.forename: S
authors.initials: S
authors.lastname: Snyder
authors.forename: C
authors.initials: C
authors.lastname: Mills
authors.forename: M
authors.initials: M
authors.lastname: Fischl
authors.forename: C
authors.initials: C
authors.lastname: Pettinelli
authors.forename: D
authors.initials: D
authors.lastname: Katzenstein
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects; D018791:CD4 Lymphocyte Count; D020008:Delavirdine / Q000008:administration & dosage; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D006801:Humans; D008297:Male; D019888:Nelfinavir / Q000008:administration & dosage; D063065:Organophosphonates; D011446:Prospective Studies; D012367:RNA, Viral / Q000032:analysis; D019438:Ritonavir / Q000008:administration & dosage; D019258:Saquinavir / Q000008:administration & dosage
chemical_list: D019380:Anti-HIV Agents; D063065:Organophosphonates; D012367:RNA, Viral; C053001:adefovir; D020008:Delavirdine; D019888:Nelfinavir; D000225:Adenine; D019258:Saquinavir; D019438:Ritonavir