Therapy with efavirenz plus indinavir in patients with extensive prior nucleoside reverse-transcriptase inhibitor experience: A randomized, double-blind, placebo-controlled trial

被引:30
作者
Haas, DW
Fessel, WJ
Delapenha, RA
Kessler, H
Seekins, D
Kaplan, M
Ruiz, NM
Ploughman, LM
Labriola, DF
Manion, DJ
机构
[1] Vanderbilt Univ, Sch Med, Div Infect Dis, Nashville, TN 37212 USA
[2] Kaiser Permanente Med Ctr, Res Unit, San Francisco, CA USA
[3] Howard Univ, AIDS Clin Trials Unit, Washington, DC 20059 USA
[4] Chicago Ctr Clin Res, Chicago, IL USA
[5] St Josephs Comprehens Res Inst, Tampa, FL USA
[6] N Shore Hlth Syst, Div Infect Dis, Ctr AIDS Res & Treatment, Manhasset, NY USA
[7] DuPont Pharmaceut Co, Wilmington, DE USA
关键词
D O I
10.1086/318083
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
A randomized, double-blind, placebo-controlled trial compared efavirenz (600 mg every 24 h) plus indinavir (1000 mg every 8 h) with placebo (every 24 h) plus indinavir (800 mg every 8 h) among 327 nucleoside analogue reverse-transcriptase inhibitor (NRTI)-experienced human immunodeficiency virus (HIV)-infected adults. Patients received less than or equal to2 concomitant NRTIs. Eligible patients had CD4 cell counts >50 cells/mm(3), >10,000 plasma HIV-1 RNA copies/mL, and no prior protease inhibitor or non-NRTI therapy. Patients had a mean of 2.8 years of prior NRTI therapy. At 24 weeks, plasma HIV-1 RNA level was <400 copies/mL in 68.2% of efavirenz versus 52.4% of placebo recipients (P = .004). CD4 cell count increases were 104 +/- 9 cells/mm(3) and 77 +/- 10 cells/mm(3) in efavirenz and placebo recipients, respectively (P = .023). Responses in efavirenz recipients were sustained at 48 weeks. Thus, efavirenz plus indinavir with concomitant NRTIs is effective therapy for NRTI-experienced patients.
引用
收藏
页码:392 / 400
页数:9
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