title: Quantitative pp65-antigenemia assay for the prediction of human cytomegalovirus disease in HIV-infected patients.
abstract: OBJECTIVE
  To evaluate the ability of a quantified pp65-antigenemia assay to predict the development of human cytomegalovirus (HCMV) disease in patients with an advanced HIV infection.
  
  
  METHODS
  A prospective longitudinal study between March 1993 and December 1996. Blood samples for the pp65-antigenemia assay were drawn at 2-3 month intervals.
  
  
  METHODS
  AIDS department of an institutional tertiary care centre.
  
  
  METHODS
  A total of 101 HIV-infected patients with CD4 lymphocyte counts of 100/mm3 or less were enrolled. Ninety-seven patients were eligible for analysis. All patients gave informed consent.
  
  
  METHODS
  The development of HCMV disease.
  
  
  RESULTS
  Of the 97 patients, 24 developed HCMV disease after a median follow-up of 10.6 months. Three months before the development of HCMV disease, an increase in the median number of pp65-antigen-positive leukocytes was observed. The highest combination of sensitivity (45%) and specificity (94%) for the development of HCMV disease within the next 3 months was found when an assay cut-off level of 48/10(5) pp65-antigen-positive leukocytes was applied, with a positive predictive value (PPV) for the development of HCMV disease of 75%. The Kaplan-Meier estimate of HCMV disease-free survival after patients reached 48/10(5) or more antigen-positive leukocytes on longitudinal follow-up was a median 3.7 months [95% confidence interval (CI), 2.5-8.5]. The hazard ratio (HR) of this threshold level for the development of HCMV disease was 9.6 (95% CI, 4.2-21.8).
  
  
  CONCLUSIONS
  Longitudinal follow-up using the pp65-antigenemia assay of HIV-infected patients with a low CD4 lymphocyte count improves the identification of patients who will develop HCMV disease in the foreseeable future, and should be considered for the selection of patients who may benefit from pre-emptive HCMV treatment.
authors.affiliation: National AIDS Therapy Evaluation Center (NATEC), Department of Internal Medicine, Amsterdam, The Netherlands. s.n.blank@amc.uva.nl
authors.forename: B S
authors.initials: BS
authors.lastname: Blank
authors.forename: P L
authors.initials: PL
authors.lastname: Meenhorst
authors.forename: G J
authors.initials: GJ
authors.lastname: Weverling
authors.forename: A A
authors.initials: AA
authors.lastname: Stout-Zonneveld
authors.forename: W
authors.initials: W
authors.lastname: Pauw
authors.forename: J W
authors.initials: JW
authors.lastname: Mulder
authors.forename: W C
authors.initials: WC
authors.lastname: van Dijk
authors.forename: P
authors.initials: P
authors.lastname: Smits
authors.forename: J M
authors.initials: JM
authors.lastname: Lange
mesh_terms: D000328:Adult; D000956:Antigens, Viral / Q000097:blood / Q000276:immunology*; D015496:CD4-Positive T-Lymphocytes / Q000276:immunology; D003586:Cytomegalovirus Infections / Q000209:etiology / Q000276:immunology*; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000276:immunology*; D015497:HIV-1; D006801:Humans; D008297:Male; D010750:Phosphoproteins / Q000097:blood / Q000276:immunology*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D012698:Serologic Tests; D016019:Survival Analysis; D014763:Viral Matrix Proteins / Q000097:blood / Q000276:immunology*
chemical_list: D000956:Antigens, Viral; D010750:Phosphoproteins; D014763:Viral Matrix Proteins; C065418:cytomegalovirus matrix protein 65kDa