Abstract:To prospectively observe the efficacy, tolerance , immune reconstruction and toxicity of longterm highly active antiretroviral therapy (HAART) in HIVinfected patients in China.MethodsFour hundred and thirtyseven HIVinfected patients initiated HAART and originally received two nucleoside reverse transcriptase inhibitors(NRTI) and one nonnucleoside reverse transcriptase inhibitors(NNRTI), and were traced HIV RNA levels, T lymphocyte subsets, blood routine tests, main laboratory parameter changes and treated for active opportunistic infections. Patients with severe side effects or virological failure changed to the second line regimens.Results437 patients from 8 hospitals received a mean of 4.69 years (3.15~7.34) followup. Total mortality was 6.86 %, and the majority of patients died within the first 6 months of the treatment. The proportion of subjects who had HIV1 RNA<500 copies/mL were 90.80%, 63.46%, 69.41%, 70.00%, and 72.22% at 1,4,5,6 and 7 year (±1 month) respectively. CD4+ T cell count were 115, 246, 301, 334, 363, 356,386 and 373 cells/μL at 0, 1, 2, 3, 4, 5, 6 and 7 year (±1 month) of followup, respectively. 67.73% of HIVinfected patients showed various drugrelated side effects, the majoriy were digestive system symptoms , neurological system symptoms, liver dysfunction, marrow toxicity ,skin rash, and hyperlipemia, et al. 19.22% of patients changed their primary regimens into other firstline drugs for drugrelated side effects, 11.67% of patients switch to secondline regimen for viral resistance. ConclusionThis paper firstly reported the 3 to 7year results from the multicenter prospective followup of HIVinfected patients in China taking potent antiretroviral therapy. The study demonstrated antiretroviral therapy with two NRTI and one NNRTI regimen may persistently suppress HIV and increase CD4 cell in a majority of subjects. The majority of subjects take firstline regimen effectively, minor switch to secondline regimen for drugrelated side effects or viral resistance.