OBJECTIVE Evaluation of high active antiretroviral therapy (HAART) in human immunodeficiency virus and acquired immunodeficiency syndrome (HIV/AIDS) patients receiving combined antiretroviral therapy in China. METHODS We initiated the first efficacy trial of zidovudine (AZT) 600 mg/d and lamivudine (3TC) 300 mg/d (brand name: Combivir) plus indinavir (2 400 mg/d) in 15 Chinese chronically infected with HIV in May 1999 at Beijing. RESULTS There was a rapid reduction of 2.7 log in the plasma viremia levels in 15 cases 3 months, after treatment, from a mean baseline of 90 743 copies/ml. The mean CD(4) cell counts increased by 67 cells/microliter from a baseline mean value of 471 cells/microliter and the mean CD(8) cell counts reduced by 192/microliter after 12 months of therapy. The ratio of CD(4)/CD(8) increased from 0.35 to 0.56. The average naive CD(4) cell (CD(45)RA + CD(62)L +) count and naive CD(8) cell (CD(45)RA + CD(62)L +) count increased 42 and 19/microliter respectively after one-year treatment. This drug regimen was well tolerated, with mild nausea in all, transient elevated serum bilirubin in three and kidney stone in two patients. CONCLUSIONS It is effective for the virus with different genotype. The results will form a scientific foundation for the development of therapeutic strategies for HIV infection in China.