Objective To observe the efficacy and safety of Aikang Granules for human immunodeficiency virus （HIV） resistance. Methods A double-blind randomized controlled trial （RCT） was designed and 100 stable acquired immunodeficiency syndrome （AIDS） patients who accepted highly active anti-retroviral therapy （HAART） for 3 to 4 years were chosen. Ninety patients who completed the observation were randomized into the treatment group and control group

with 45 in each. Aikang Granules or placebo was given to the treatment group and control group respectively on the basis of HAART. The treatment lasted for 9 month. The CD4+T cell count and HIV viral load （HIVVL） was detected. The immunological efficacy and HIVVL efficacy was evaluated. The prevalence of drug-resistant HIV and adverse reactions were observed. Results The prevalence of drug-resistant HIV in the treatment group was 21.43% and 23.81% before and after treatment respectively. The prevalence of drug-resistant HIV in the control group was 27.27% and 30.00% before and after treatment respectively. There was no significant difference between groups in the prevalence of drug-resistant HIV （P>0.05）. The CD4+T cell count was significantly decreased in the control group （P<0.05）. There was no significant difference in CD4+T cell count after treatment in the treatment group （P>0.05）. There was no significant change in HIVVL and HIVVL efficacy after treatment in both groups （P>0.05）. There was no adverse reaction in both groups. Conclusion Aikang Granules can improve the immune function of drug-resistant HIV patients.