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.
Conclusion: 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.