Clinical and immunologic progression in HIV-infected US women before and after the introduction of highly active antiretroviral therapy

Objective: To examine factors associated with clinical and immunologic HIV disease progression in a cohort of US women. Design: Analysis of data from a prospective, longitudinal, case-control study of HIV-infected women followed every 6 months for 7 years. Setting: Four urban clinical centers in the United States. Participants: 648 HIV-infected women who did not have AIDS at time of entry into the study. Measurements: Structured clinical and behavioral interviews; protocol-directed physical examinations; CD4 lymphocyte counts; plasma HIV RNA; infectious pathogen serologies. Results: With 2304 women-years of follow-up, 46.1% of the women developed AIDS; however, 93.3% of the diagnoses were based on CD4 counts dropping to <200 cells/mm³. Only 10.6% of the women with CD4 counts <200 cells/mm³ developed an opportunistic infection. Baseline CD4 count was the strongest predictor of subsequent clinical progression. Illicit substance use, multiple pregnancies, demographic variables, and other infections were not associated with progression. Among women with CD4 counts >500 cells/mm³ at baseline, those who were anemic or had hepatitis C were more likely to progress to AIDS. By the end of the study, only 52% of the participants were on highly active antiretroviral therapy (HAART). Conclusions: Despite underutilization of HAART in this multicenter cohort of urban women, opportunistic infections were uncommon, despite CD4 declines.