title: A randomized study of the utility of human immunodeficiency virus RNA measurement for the management of antiretroviral therapy.
abstract: To compare frequent measurement with infrequent measurement of human immunodeficiency virus (HIV) RNA levels in the management of antiretroviral therapy, we conducted a clinical strategy study of 206 HIV-infected patients who had <500 CD4 cells/mm(3). Patients were randomized (1.5:1) to undergo frequent monitoring (at baseline and every 2 months) or infrequent monitoring (at baseline and twice yearly), with CD4 cell counts determined every 2 months. Patients received unrestricted antiretroviral therapy. In the primary analysis (at month 6), the frequent group had a mean HIV RNA reduction (+/- standard deviation) of 0.93+/-0.79 log(10) copies/mL, versus 0.48+/-0.83 log(10) copies/mL for the infrequent group (P=.0002). A trend (P=.1) toward improved survival was seen in the frequent group. Given this improved virological response, more frequent HIV RNA measurement than is recommended in published guidelines (every 3-4 months) may be appropriate.
authors.affiliation: Department of Medicine and University of California-San Diego (UCSD) Treatment Center Data and Biostatistical Unit, UCSD, San Diego, CA 92103, USA. rhaubrich@ucsd.edu.
authors.forename: R H
authors.initials: RH
authors.lastname: Haubrich
authors.forename: J S
authors.initials: JS
authors.lastname: Currier
authors.forename: D N
authors.initials: DN
authors.lastname: Forthal
authors.forename: G
authors.initials: G
authors.lastname: Beall
authors.forename: C A
authors.initials: CA
authors.lastname: Kemper
authors.forename: D
authors.initials: D
authors.lastname: Johnson
authors.forename: M P
authors.initials: MP
authors.lastname: Dubé
authors.forename: J
authors.initials: J
authors.lastname: Hwang
authors.forename: J M
authors.initials: JM
authors.lastname: Leedom
authors.forename: J
authors.initials: J
authors.lastname: Tilles
authors.forename: J A
authors.initials: JA
authors.lastname: McCutchan
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1 / Q000302:isolation & purification* / Q000502:physiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood*; D016896:Treatment Outcome
chemical_list: D019380:Anti-HIV Agents; D012367:RNA, Viral