Indinavir, nevirapine, stavudine, and lamivudine for human immunodeficiency virus-infected, amprenavir-experienced subjects: AIDS Clinical Trials Group protocol 373.
This prospective, multicenter, open-label study was designed to determine the antiretroviral activity and safety of a 4-drug regimen: 1000 mg indinavir every 8 h with 200 mg nevirapine, 40 mg stavudine, and 150 mg lamivudine, each given twice daily in amprenavir-experienced subjects. The primary end points of the study were the human immunodeficiency virus (HIV) RNA level and CD4 cell count responses. Fifty-six subjects were enrolled and were changed from amprenavir-containing regimens to the 4-drug regimen. Overall, at week 48, 33 (59%) of 56 subjects had HIV RNA levels <500 copies/mL (intent-to-treat analysis, where missing values equal > or =500 copies/mL) and CD4 cell counts increased by 94 cells/mm(3) from baseline. Subjects who had previously taken amprenavir combination therapy were more likely to experience virologic failure than those who had taken amprenavir monotherapy (odds ratio, 7.7; P=.0012). In this study, most subjects who had taken amprenavir-based regimens and who changed to a 4-drug regimen achieved subsequent durable virologic suppression.
Gulick
R M
RM
Weill Medical College of Cornell University and New York University School of Medicine, Cornell Clinical Trials Unit, New York, NY 10021, USA. rgulick@med.cornell.edu
Smeaton
L M
LM
D'Aquila
R T
RT
Eron
J J
JJ
Currier
J S
JS
Gerber
J G
JG
Acosta
E
E
Sommadossi
J P
JP
Tung
R
R
Snyder
S
S
Kuritzkes
D R
DR
Murphy
R L
RL
D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D002219:Carbamates; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D005260:Female; D005663:Furans; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D019469:Indinavir / Q000008:administration & dosage / Q000627:therapeutic use; D019259:Lamivudine / Q000008:administration & dosage / Q000627:therapeutic use; D008297:Male; D019829:Nevirapine / Q000008:administration & dosage / Q000627:therapeutic use; D016017:Odds Ratio; D011446:Prospective Studies; D012367:RNA, Viral / Q000032:analysis*; D012449:Safety; D018119:Stavudine / Q000008:administration & dosage / Q000627:therapeutic use; D013449:Sulfonamides / Q000008:administration & dosage / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load
D019380:Anti-HIV Agents; D002219:Carbamates; D005663:Furans; D012367:RNA, Viral; D013449:Sulfonamides; D019259:Lamivudine; C095108:amprenavir; D019469:Indinavir; D019829:Nevirapine; D018119:Stavudine