title: HIV and cytomegalovirus viral load and clinical outcomes in AIDS and cytomegalovirus retinitis patients: Monoclonal Antibody Cytomegalovirus Retinitis Trial.
abstract: OBJECTIVE
  To determine the association of cytomegalovirus (CMV) viremia with mortality and CMV retinitis progression in newly diagnosed and relapsed CMV retinitis.
  
  
  METHODS
  Ancillary study of a randomized, placebo-controlled, phase III clinical trial.
  
  
  METHODS
  A total of 83 patients with AIDS and CMV retinitis, enrolled during the first phase of the Monoclonal Antibody Cytomegalovirus Retinitis Trial, were administered MSL-109 or placebo as adjuvant therapy for CMV retinitis.
  
  
  METHODS
  Mortality and CMV retinitis progression.
  
  
  RESULTS
  Treatment with MSL-109 did not predict either progression of CMV retinitis or mortality. Detection in plasma CMV DNA at baseline predicted mortality, but CMV antigenemia did not. CMV DNA was a better predictor of mortality than a high HIV viral load. Neither CMV DNA nor antigenemia predicted the progression of CMV retinitis. Among newly diagnosed patients, there was a decline in the proportion with detectable CMV viral load and CMV antigenemia in response to anti-CMV therapy. However, there was a rebound in CMV viral load to 25% and CMV antigenemia to 54.6% at 6 months. In relapsed patients, anti-CMV therapy was not associated with a change in the percentage with detectable CMV-DNA or CMV antigenemia over time.
  
  
  CONCLUSIONS
  In patients with AIDS and CMV retinitis, the detection of plasma CMV DNA was associated with a higher risk of mortality than was a high HIV viral load. Anti-CMV therapy provided a transient reduction in CMV viremia in newly diagnosed but not relapsed patients with CMV retinitis. Adjuvant therapy with MSL-109 was ineffective in clearing CMV-DNA and CMV antigen from the plasma.
authors.affiliation: Department of Ophthalmology, The Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA.
authors.forename: Douglas A
authors.initials: DA
authors.lastname: Jabs
authors.forename: Adele M Kaplan
authors.initials: AM
authors.lastname: Gilpin
authors.forename: Yuan-I
authors.initials: YI
authors.lastname: Min
authors.forename: Alejo
authors.initials: A
authors.lastname: Erice
authors.forename: John H
authors.initials: JH
authors.lastname: Kempen
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Quinn
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000150:complications / Q000628:therapy* / Q000821:virology; D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D000956:Antigens, Viral / Q000097:blood; D003587:Cytomegalovirus / Q000235:genetics / Q000276:immunology / Q000302:isolation & purification*; D017726:Cytomegalovirus Retinitis / Q000150:complications / Q000628:therapy* / Q000821:virology; D004279:DNA, Viral / Q000097:blood; D005260:Female; D006801:Humans; D008297:Male; D010919:Placebos; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000911:Antibodies, Monoclonal; D000956:Antigens, Viral; D004279:DNA, Viral; D010919:Placebos; C409204:sevirumab