Abstract： Objective To evaluate the safety and tolerance of the first-line hiighly active antiretroviral therapy(HAART)regimen in Chinese HIV/AIDS patients.Methods The clinical data and laboratory results were retrospectively reviewed in 95 HIV/AIDS outpatients receiving first-line HAART regimen of zidovudine,lamivudine and efavirenz(or nevirapine)in Public Heahh Clinical Center Affiliated to Fudan University during January 2005 and August 2008.Mixed effects model and X2 test or Fisher test were used to analyze panel data and ratio data respectively.Results Totally 81%(77/95)patients had adverse events in the course of treatment,11.6%(11/95)developed grade 3 or higher adverse effects.Hematological adverse events and hepatotoxity were the most common in term of laboratory events with the total incidence of 46.3%(44/95)and 27.4%(26/95)respectively;8.4%(8/95)and 6.3%(6/95)were grade 3 or higher.In clinical events,30.5%(29/95),37.8%(36/95)and 27.4%(26/95)patients had dermatological,gastrointestinal and neurological adverse events respectively,however,only 1.1%(1/95)experienced grade 3 or higher dermatological adverse events.Conclusion The first line HAART regimen is safe and well tolerated in Chinese HIV/AIDS patients.