Objective To observe the therapeutic effect of qi-boosting spleen-fortifying therapy combined with highly active antiretroviral therapy（HAART）on human immunodeficiency virus infection/acquired immunodeficiency syndrome（HIV/ AIDS）.Methods Totally 86cases of HIV/AIDS were randomized into the treatment group and control group

with 43cases in each.The treatment group was given qi-boosting spleen-fortifying formulas combined with HAART.The control group was given HAART.Observed indicators including CD4+T cell count

symptom and sign integral

Karnofsky performance scale（KPS）and liver function before

6months and 12months after treatment.The therapeutic effect was judged after 12-month treatment.Results There were 5cases（11.63%）and 6cases（13.95%）of endpoint events occurred in the treatment group and control group respectively

with no significant difference between groups（P>0.05）.The symptom and sign scores were significantly decreased but the KPS scores were significantly increased in both groups after 6-month and 12-month treatment（P<0.05）.There were significant differences between groups in the symptom and sign scores and KPS scores after 6-month treatment（P<0.05）

but there was no significant difference between groups after 12-month treatment（P>0.05）.The CD4+ T cell count was significantly increased in both groups after 6-month and 12-month treatment（P<0.05）

but with no significant difference between groups（P>0.05）.The level of Alanine aminotransferase（ALT）was significantly decreased in the treatment group but significantly increased in the control group after 6-month and 12-month treatment（P<0.05）.There was no significant difference between groups in ALT after 6-month treatment（P>0.05）

but with a significant difference between groups after 12-month treatment（P<0.01）.Conclusion The combo therapy of qi-boosting spleen-fortifying therapy and HAART can relieve symptoms and signs

improve quality of life and reduce liver damage.