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Session 7 Oral Abstract Session Opportunistic Infections and Complications of Antiretroviral Therapy Session Time: Monday, 10 am - 12:30 pm Room 6E

11:45   38. CMV and HIV Viral Burden and Development of CMV End-Organ Disease: a Prospective Study in HIV-Infected Subjects (ACTG 360) A. Erice*1, C. Tierney2, M. Hirsch2, A. Caliendo3, A. Weinberg4, M. Kendall2, and B. Polsky5 for the ACTG 360 Study Team 1Univ. of Minnesota, Minneapolis; 2Harvard Univ., Boston, MA; 3Emory Univ., Atlanta, GA; 4Univ. of Colorado, Denver; and 5Columbia Univ., New York, NY 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/mm3) 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/mm3) 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.

©2002 9th Conference on Retroviruses and Opportunistic Infections