<p><b>OBJECTIVE</b>To determine the effect of national free highly active antiretroviral treatment (HAART) on reduction of mortality and relevant risk factors among adult Acquired immunodeficiency syndrome (AIDS) patients.</p><p><b>METHODS</b>A retrospective cohort study was conducted and all AIDS patients diagnosed before Aug. 30th, 2008 in Zhumadian, Henan province, and Fuyang, Anhui province were enrolled in this study, where HAART initiated in early time. The data and information were collected such as AIDS progress, diagnosis, treatment, death and et al.</p><p><b>RESULTS</b>Among 10,394 AIDS patients, the mean age was (41.7 +/- 9.3) year-old, 50.3% (5233/10,394) were male, 85.0% (8808/10,394) were married, 95.1% (9880/10,394) were farmers, and 81.2% (8438/10,394) were former plasma donors (FPDs). The coverage of HAART increased from 5.2% in 2002 to 66.5% in 2008. Conversely, the overall mortality declined from 35.4/100 person-years in 2002 to 5.9/100 person-years in 2008. In a multivariate Cox proportional hazards analysis, the greatest risk factor for mortality was non-HAART, with a hazard ratio (HR) 4.3 (95%CI: 4.0 - 4.7). Among treated patients, compared with higher CD(4)(+) T cell counts (> 200 cells/microl), those initiating therapy with lower CD(4)(+) T cell counts, were at greater risk to death (< 50 cells/microl, HR = 7.9; 50 - 199 cells/microl, HR = 2.8). Number of opportunistic infections (OIs) was risk to mortality (HR = 2.1). In addition, other risk factors included male, age (>or= 50 years old), and other infection way except FPDs (HR were 1.4, 1.6 and 1.8).</p><p><b>CONCLUSION</b>The national free treatment program has significantly reduced the AIDS mortality rate among HIV-infected FPDs through the use of generic antiretroviral drugs in rural clinical settings. The effective reduction of AIDS mortality could be realized through increased coverage of therapy.</p>