Risk factors for mortality in patients with AIDS in the era of highly active antiretroviral therapy.

OBJECTIVE

To evaluate risk factors for mortality among patients with AIDS in the era of highly active antiretroviral therapy (HAART), particularly the effect of cytomegalovirus (CMV).

DESIGN

Prospective cohort study of patients with AIDS, conducted from 1998 through 2003.

PARTICIPANTS

One thousand five hundred eighty-three patients with AIDS, of whom 374 had CMV retinitis.

METHODS

Patients were contacted every 3 months, with examinations at least every 6 months, in which standardized data were collected on AIDS history and treatment, eye examinations, and hematologic, virologic, and immunologic laboratory data.

MAIN OUTCOME MEASURE: Mortality.

RESULTS

The overall mortality rate was 0.07 deaths/person-year. In a multivariate analysis, the following baseline risk factors were associated with an increased mortality: higher human immunodeficiency virus (HIV) viral load (relative risk [RR] = 4.6 for HIV viral load >100,000 copies/ml vs. <400 copies/ml; P<0.0001), lower CD4+ T-cell count at enrollment (RR = 3.8 for CD4+ T cell count 0-49 cells/microl vs. > or = 200 cells/microl; P<0.0001), CMV viral load > or = 400 copies/ml (RR = 1.9; P = 0.002), lower hemoglobin (RR = 1.7 for hemoglobin <10 g/dl; P = 0.009), a history of cryptococcal meningitis (RR = 1.7; P = 0.02), CMV retinitis (RR = 1.6; P = 0.0002), and Karnofsky score < or = 80 (RR = 1.4; P = 0.008).

CONCLUSIONS

In the era of HAART, CMV disease as manifested by CMV retinitis and a detectable CMV viral load were associated with an increased risk for mortality, even after adjusting for demographic, treatment, immunologic, and HIV virologic factors.