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Details of the recruitment and characteristics of the MACS cohort have been described elsewhere (9). The MACS protocol was approved by the Biomedical Institutional Review Board of the University of Pittsburgh. All subjects gave written informed consent after the potential consequences of study participation were explained.
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+ T cells by the total lymphocyte count.
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13344253978
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For subjects developing AIDS, the samples tested were from study entry, the first follow-up visit (6 months), the most recent visit before AIDS diagnosis, and equally spaced visits in between. For AIDS-free subjects, the samples tested were from study entry, the 6-month follow-up visit, the last available visit, and equally spaced visits in between.
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Developed by Chiron, the assay measures HIV-1 RNA associated with viral particles that are separated from 1.0-ml plasma samples by centrifugation at 23,500g for 1 hour at 4°C. Performance characteristics of the assay have been described elsewhere (14). For our study, the interassay coefficient of variation for the positive control samples tested with each batch of experimental samples was 18%. All samples were coded and the assay operators were blinded to clinical outcomes.
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13344251151
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note
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We thank the participants and staff of the Pitt Men's Study for their dedication and support. Supported by Public Health Service contract N01-Al-72632 and cooperative agreement U01-Al-35041 and by grant support from the National Institutes of Health (R01 Al34301-01 and Al34294-01A2), the Medical Research Service of the Department of Veterans Affairs, and the Pathology Education and Research Foundation of the University of Pittsburgh.
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