Abstract: Objective To evaluate the immunological and virological effect of HIV/AIDS highly active antiretroviral therapy (HAART) program on HIV-infected patients in Guangdong. Methods Data of HAART for HIV/AIDS cases in Guangdong Province were obtained from national HIV/AIDS comprehensive information system. The effectiveness of HAART in immunity recovery and viral suppression was estimated by using CD4+T lymphocytes and virus load. Results A total of 12 886 AIDS patients were treated during 2004 to 2013 in Guangdong Province, including 9 393 males and 3 493 females. Their mean age was (40.94±11.87) years and the mean treatment duration was (28.17±24.28) months. At baseline, 61.63% (7 941/12 886) of the patients had CD4+T lymphocytes less than 200 cells/μL, 33.08% (4 263/12 886) had 200-350 cells/μL, and 5.29%（682/12 886）had more than 350 cells/μL. After HAART, 21.32% (2 747/12 886) of the patients had CD4+T lymphocytes < 200 cells/μL, 31.17% (4 017/12 886) had 200-350 cells/μL, and 47.51% (6 122/12 886) had >350 cells/μL, respectively. Compared with those at baseline,the counts of CD4+T lymphocytes of the patients increased obviously after HAART (P＜0.01 for all). Of 12 866 patients completing HAART, 11 053 had HIV viral load<400 copy/mL with a viral inhibitory rate of 85.78%. The viral inhibitory rates were 14.42%, 84.25%, 91.01％, 90.56%, and 90.86％ in the patients after HARRT for 3 months, 6 months, 1 year, 2 years, and 3 years, respectively. Conclusion HIV/AIDS patients in Guangdong Province showed good virological and immunological responses to HAART. The current China's national HAART regimens were effective and the coverage of antiviral treatment should be improved.