title: Low rate of CMV end-organ disease in HIV-infected patients despite low CD4+ cell counts and CMV viremia: results of ACTG protocol A5030.
abstract: OBJECTIVE
  To describe cytomegalovirus (CMV) end-organ disease (EOD) rate in AIDS patients with low CD4+ cell count despite HAART who were enrolled in a randomized, placebo-controlled trial of preemptive valganciclovir (VGCV) to prevent CMV EOD in those with CMV viremia.
  
  
  METHODS
  Subjects (N = 338) were HIV-infected with CD4+ count <100 cells/mm3, plasma HIV RNA >400 copies/mL, and on stable or no HAART. All underwent plasma CMV DNA PCR testing every 8 weeks (Step 1); those with detectable CMV DNA were randomized to VGCV or placebo (Step 2).
  
  
  RESULTS
  Plasma CMV DNA was detected in 68 (20%), of whom 4 developed CMV EOD. During Step 1, 53 died. Of the 47 who entered Step 2 (24 VGCV, 23 placebo), CMV EOD was diagnosed in 10 (4 VGCV, 6 placebo) and 15 died (7 VGCV, 8 placebo). Of those randomized to placebo, 14% were diagnosed with CMV EOD at 12 months.
  
  
  CONCLUSIONS
  We observed a lower CMV EOD rate among subjects receiving HAART than predicted based on published literature. However, mortality was high in this study. Our findings suggest that preemptive anti-CMV therapy in patients with persistently low CD4+ cell counts in the current treatment era may not be warranted given the low incidence of CMV EOD and high all-cause mortality observed in this study population.
authors.affiliation: University of North Carolina, Chapel Hill, North Carolina, USA. wohl@med.unc.edu
authors.forename: D A
authors.initials: DA
authors.lastname: Wohl
authors.forename: M A
authors.initials: MA
authors.lastname: Kendall
authors.forename: J
authors.initials: J
authors.lastname: Andersen
authors.forename: C
authors.initials: C
authors.lastname: Crumpacker
authors.forename: S A
authors.initials: SA
authors.lastname: Spector
authors.forename: J
authors.initials: J
authors.lastname: Feinberg
authors.forename: B
authors.initials: B
authors.lastname: Alston-Smith
authors.forename: S
authors.initials: S
authors.lastname: Owens
authors.forename: S
authors.initials: S
authors.lastname: Chafey
authors.forename: M
authors.initials: M
authors.lastname: Marco
authors.forename: S
authors.initials: S
authors.lastname: Maxwell
authors.forename: N
authors.initials: N
authors.lastname: Lurain
authors.forename: D
authors.initials: D
authors.lastname: Jabs
authors.forename: C
authors.initials: C
authors.lastname: Benson
authors.forename: P
authors.initials: P
authors.lastname: Keiser
authors.forename: M A
authors.initials: MA
authors.lastname: Jacobson
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy / Q000401:mortality* / Q000821:virology*; D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy / Q000821:virology; D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D000998:Antiviral Agents / Q000008:administration & dosage; D018791:CD4 Lymphocyte Count; D003587:Cytomegalovirus / Q000235:genetics / Q000302:isolation & purification; D003586:Cytomegalovirus Infections / Q000188:drug therapy / Q000401:mortality* / Q000821:virology; D004311:Double-Blind Method; D015774:Ganciclovir / Q000008:administration & dosage / Q000031:analogs & derivatives; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy / Q000401:mortality; D006801:Humans; D008875:Middle Aged; D016133:Polymerase Chain Reaction; D016016:Proportional Hazards Models; D000077562:Valganciclovir; D014766:Viremia / Q000188:drug therapy / Q000453:epidemiology*
chemical_list: D000998:Antiviral Agents; D000077562:Valganciclovir; D015774:Ganciclovir