ObjectiveTo evaluate the preliminary efficacy and safety of compound astragalus mongholicus granule in the 24week treatment of patients infected with HIV.MethodsTwentytwo patients infected with HIV received an oral administration of compound astragalus mongholicus granule for 24 weeks. HIV RNA were detected at week 0 and week 24; CD4+, CD8+ cell counts and levels of cytokines (IL2, IL4, IFNγ) were examined at week 0, week 8 and week 24. Clinic symptoms, blood routine examination, liver and renal function and adverse events were recorded at week 0, 8, 16 and 24, respectively. ResultsThe CD4+ cell counts increased 22 cell/μL (t=2.08，P＝0.03) when compared with the baseline. IL2 and IFNγ increased 7.29pg/mL and 3.82pg/mL respectively (t＝3.46，P＝0.00；t＝5.94，P＝0.00),while IL4 reduced 3.71pg/mL(t=8.18，P＝0.00); HIV RNA deceased 0.40 lg copy/mL(t=2.65，P＝0.02); 6 patients gained weight of more than 2 kg, 10 patients gained weight of no more than 2 kg. The results of blood routine examination, liver and renal function were normal. No obvious adverse events were observed. ConclusionCompound astragalus mongholicus granule can increase the number of CD4+ cells in patients infected with HIV, inhibit HIV replication and with immune regulation function to a certain extent. It can also improve HIV infection symptoms and gain the patients’ weight. No obvious side effects were observed in this clinical trial.