AEGiS-11IAC: Prospective evaluation of cytomegalovirus (CMV) antigenemia and DNA hybridization assays in HIV-infected persons at risk for CMV disease.

11th International AIDS Conference

Vancouver, British Columbia — July 7-12, 1996

Prospective evaluation of cytomegalovirus (CMV) antigenemia and DNA hybridization assays in HIV-infected persons at risk for CMV disease.

Int Conf AIDS 1996 Jul 7-12; 11:218 (abstract no. Th.A.392)
Mazzulli T, Wood S, Chua R, Phillips A, Fong IW, Rachlis A, Krajden M, Mortimer C, Clark J, Walmsley S; Mount Sinai Hospital, Toronto, Ontario, Canada. Fax: 416-586-8746.

OBJECTIVE: To prospectively evaluate the utility of the CMV antigenemia assay and a DNA hybridization assay as early predictors of CMV disease in HIV-infected persons at high risk for developing end-organ CMV disease.

METHODS: HIV-positive patients with CD4 cell counts less than or equal to 50 x 106/L, with no evidence of end-organ CMV disease and who were not receiving CMV therapy were followed on a monthly basis with clinical evaluations and laboratory testing for CMV in blood using antigenemia, DNA hybridization and culture.

RESULTS: Ninety-six patients were followed for a median of 9 months (range 1 to 15 months) of which 16 developed CMV end-organ disease (13 retinitis, 1 each of colitis, pneumonitis, and myelitis). Using receiver operating characteristic (ROC) curves, both the quantitative antigenemia and DNA assays were significantly (p is less than 0.01) better predictors of CMV end-organ disease than cultures of blood or urine. As well, the negative predictive value of these assays was excellent, as no patient with a negative antigenemia or DNA assay result developed CMV disease during the study. Individual patient profiles indicate that some patients develop end-organ CMV disease concomitant with the peak level of CMV antigenemia or DNA, whereas others develop disease weeks to months after clearance of CMV from their blood. There was a correlation between the peak antigen and DNA levels and the time to development of CMV end-organ disease. Patients who developed CMV end-organ disease tended to have both CMV antigen and DNA levels that were substantially greater than those who did not.

CONCLUSIONS: The results of our study suggest that in HIV-infected patients who are at risk for developing CMV end-organ disease, both the antigenemia assay and the DNA assay could be used to identify those patients likely to progress to CMV end-organ disease. Both assays appear to have much better sensitivity and specificity than conventional cultures of either blood or urine. The utility of these two assays requires further investigation but suggests that they may be used to select those patients who may most benefit from prophylactic or pre-emptive CMV therapy prior to the development of CMV end-organ disease.

Keywords: AEGIS, Cytomegalovirus, Cytomegalovirus Infections, Antineoplastic Combined Chemotherapy Protocols, CD4 Lymphocyte Count, Evaluation Studies, Cytomegalovirus Retinitis, HIV Infections, HIV Seropositivity, Sensitivity and Specificity, MEC protocol 1, Human, ICA11

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ThA392