title: Therapy with efavirenz plus indinavir in patients with extensive prior nucleoside reverse-transcriptase inhibitor experience: a randomized, double-blind, placebo-controlled trial.
abstract: 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 </=2 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.
authors.affiliation: Division of Infectious Diseases, Vanderbilt University, Nashville, Tennessee 37212, USA. david.w.haas@vanderbilt.edu
authors.forename: D W
authors.initials: DW
authors.lastname: Haas
authors.forename: W J
authors.initials: WJ
authors.lastname: Fessel
authors.forename: R A
authors.initials: RA
authors.lastname: Delapenha
authors.forename: H
authors.initials: H
authors.lastname: Kessler
authors.forename: D
authors.initials: D
authors.lastname: Seekins
authors.forename: M
authors.initials: M
authors.lastname: Kaplan
authors.forename: N M
authors.initials: NM
authors.lastname: Ruiz
authors.forename: L M
authors.initials: LM
authors.lastname: Ploughman
authors.forename: D F
authors.initials: DF
authors.lastname: Labriola
authors.forename: D J
authors.initials: DJ
authors.lastname: Manion
mesh_terms: D000328:Adult; D000480:Alkynes; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D048588:Benzoxazines; D018791:CD4 Lymphocyte Count; D003521:Cyclopropanes; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1 / Q000302:isolation & purification / Q000502:physiology; D006801:Humans; D019469:Indinavir / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010078:Oxazines / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D010078:Oxazines; D012367:RNA, Viral; D018894:Reverse Transcriptase Inhibitors; D019469:Indinavir; C098320:efavirenz