9th Conference on Retroviruses and Opportunistic Infections Seattle, Washington - February 24 -February 28, 2002

Conf Retroviruses Opportunistic Infect 2002 Feb 24-28;9:abstract no. 38
Erice A, Tierney C, Hirsch M, Caliendo A, Weinberg A, Kendall M, Polsky B, The ACTG 360 Study Team; Univ. of Minnesota, Minneapolis

BACKGROUND: In advanced HIV infection, the relationships between CMV burden, HIV burden, and risk for developing CMV end-organ disease (EOD) are not well established.

METHODS: ACTG 360 was a 3-year observational study of CMV EOD in HIV-infected subjects without prior CMV EOD and a CD4 cell count of 50 cells/mm³ within 24 months before study entry. Blood samples were collected every 16 weeks, and ophthalmologic exams were done every 6 months. CMV DNA was measured in plasma by PCR (Roche), and in whole blood by hybridization (Digene). Plasma HIV RNA was measured by a bDNA assay (Bayer).

RESULTS: 403 subjects were followed for a median of 151 weeks. Their baseline characteristics were: median CD4 cell count: 114 cells/mm³ (27% with 50 cells/mm³); median plasma HIV RNA: 3.64 log₁₀ copies/mL (32% with 50 copies/mL); median length of prior antiretroviral therapy: 1.2 years. At baseline, 87% of 311 subjects had 200 CMV DNA copies/mL of blood (Digene), and 99% of 374 subjects had 400 CMV DNA copies/mL of plasma (Roche). During the study, CMV DNA remained 200 copies (Digene) and 400 copies (Roche) in > 85% and > 97% of subjects, respectively. 21 subjects developed CMV EOD (17 retinitis), with a cumulative incidence at 1 year (Inc.) of 2.3% (95% CI: 0.8%, 3.9%). 20 of these 21 subjects had low CD4 cell counts (<50 cells/m(3)) and high plasma HIV RNA levels (>4 log₁₀ copies/mL) at baseline. In subjects with low CD4 cell counts and high plasma HIV RNA at baseline (n=60), CMV DNA level at baseline was not associated with development of CMV EOD (15 events; Inc. of 20% and 11% for CMV DNA > or 200 copies/mL, respectively; p=0.28). 56 subjects died during the study period, resulting in an estimated mortality rate of 5.7 deaths per 100 person-years (95% CI: 4.4, 7.4).

CONCLUSIONS: This study found low incidence of CMV EOD and relatively high mortality. CMV EOD was strongly associated with low CD4 count (<50 cells/m(3)) and high plasma HIV RNA (>4 log₁₀ copies/mL). CMV DNA levels were low in the vast majority of subjects and not significantly associated with development of CMV EOD.

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Copyright © 2002 - Foundation for Retrovirology and Human Health. Reproduction of this abstract (other than one copy for personal reference) must be cleared through the Foundation for Retrovirology and Human Health. Licensed (AIDSLINE) from National Library of Medicine.