Abstract： Objective： To observe the clinical effect of Aifukang capsules combined with highly active anti- retroviral therapy(HAART) on acquired immune deficiency syndrome. Methods： A total of 90 acquired immune deficiecy syndrome patients were selected and divided into the treatment group and the control group according to the odd- even number of admission，45 cases in each group. The control group was treated with HAART，and the treatment group was additionally treated with Aifukang capsules based on the treatment of the control group. Both groups were treated for six months. The clinical effect and adverse reactions were compared between the two groups； the immune function， virus suppression， score of patient reported outcome(PRO)，liver and kidney function were compared between the two groups before and after treatment. Results：The total effective rate was 91.11% in the treatment group，higher than that of 66.67% in the control group(P＜0.05). After treatment，levels of CD4 + and CD4 +/CD8 + value in the treatment group were higher than those in the control group(P＜0.05)；there was no significant difference in the CD8+ levels between the two groups(P＞0.05)；the levels of total bilirubin(TBil)，alanine aminotransferase(ALT) and serum creatinine(SCr) in the treatment group were lower than those in the control group(P＜0.05). Viral load in the treatment group was smaller than that in the control group(P＜0.05)；the virus inhibition rate in the treatment group was 62.22%，higher than that of 40.00% in the control group(P＜0.05). The scores of physiological field，psychological field and social field in the treatment group were lower than those in the control group(P＜ 0.05). The incidence of adverse reactions in the treatment group was 26.67%，lower than that of 48.89% in the control group (P＜0.05). Conclusion：Aifukang capsules combined with HAART in the treatment of acquired immune deficiency syndrome can improve the clinical effect， inhibit human immunodeficiency virus， improve the body immunity and PRO， reduce the incidence of adverse reactions.