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.
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.
Gulick
R M
RM
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
Hu
X J
XJ
Fiscus
S A
SA
Fletcher
C V
CV
Haubrich
R
R
Cheng
H
H
Acosta
E
E
Lagakos
S W
SW
Swanstrom
R
R
Freimuth
W
W
Snyder
S
S
Mills
C
C
Fischl
M
M
Pettinelli
C
C
Katzenstein
D
D
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
D019380:Anti-HIV Agents; D063065:Organophosphonates; D012367:RNA, Viral; C053001:adefovir; D020008:Delavirdine; D019888:Nelfinavir; D000225:Adenine; D019258:Saquinavir; D019438:Ritonavir