Objective  To examine the status of AIDS patients receiving highly active antiretroviral therapy (HAART) in Hubei province between 2003 – 2015 and to analyze the immunological failure of HAART and its influencing factors among the patients.

  Methods  We extracted relevant data on AIDS patients receiving HAART from National Information System for Comprehensive AIDS Prevention and Control to analyze outcomes and immunological failure of HAART among the AIDS patients. The influencing factors of immunological failure of HAART were analyzed with Cox risk model involving time-dependent variables.

  Results  Totally 60 018 follow-up visits were conducted among 8 996 AIDS patients enrolled. Immunological failure were identified among 30.55% of the patients being followed-up and the median time for the failures was 47.67 months from the beginning of HAART. The results of expanded Cox risk model analysis demonstrated that the number of missed dose of HAART during previous 7 days before the fellow-up, gender, clinical staging based on World Health Organization criterion, CD4⁺ T lymphocyte baseline count, age (50 years old and above), and the initial treatment scheme were impact factors for immunological failure of HAART among the patients.

  Conclusion  Many factors influence the incidence of immunological failure among AIDS patients receiving HAART and improving therapeutic compliance, conducting antiviral therapy as early as possible, adopting appropriate treatment scheme, and paying special concern on the therapy for elderly patients are measures to decrease the immunological failure.