The study was approved by the Committee on Human Research of the University of California, San Francisco. A retrospective cohort study design was used to evaluate outcomes including mortality while on treatment for tuberculosis. A standard data collection form was used to record information extracted from all patient records, including HIV serostatus, history of opportunistic infections, tuberculosis, co-morbid conditions, chest radiograph results, bacteriology results, treatment regimen, use of directly observed therapy (DOT) and interruptions of treatment due to non-adherence or adverse reactions to tuberculosis medications. DOT was categorized as "full" (throughout treatment) or "partial" (during intensive phase of treatment only). San Francisco Tuberculosis Control Program requires treatment be initiated under DOT for patients with any of the following characteristics: sputum smear positive for acid fast bacilli, suspected or confirmed drug resistant disease, HIV co-infection, slow sputum conversion, homeless/shelter resident, history of intravenous or non-intravenous drug use, psychological disorder, alcohol abuse, history of prior tuberculosis, and when the treating clinician deems patient too infirm to self manage or suspects high likelihood of non-adherence. Viral load and CD4+ T lymphocyte counts were provided by the San Francisco AIDS Registry. HIV status was unknown in 99 (17.5%) patients. As part of the parent study, rigorous evaluation of the medical records confirmed that these patients had no identifiable risk factors for HIV [11 (link)]. All patients received a rifamycin-based regimen for active pulmonary tuberculosis approved by the American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America [9 (link)]. Rifabutin was used in place of rifampin in all patients receiving highly active antiretroviral treatment (HAART) and tuberculosis treatment.
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