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Background: The combination of highly active antiretroviral therapy (HAART) and liposomal doxorubicin is a promising approach for the treatment of progressive HIV-related Kaposi's sarcoma (KS). Here, we determined the safety, tolerability, and efficacy of liposomal doxorubicin and HAART as a combined treatment approach for advanced KS, and assessed the impact of liposomal doxorubicin on HAART-mediated immune reconstitution and viral suppression. Patients and Methods: In an uncontrolled observational trial, KS treatment responses were assessed in 54 HIV-1- infected patients with advanced KS according to ACTG criteria. Immunological and virological treatment responses were compared to 54 non-KS-affected HIV-1 patients who were individually matched to the study participants according to sex, age (± 5 years), CD4+ T cell count (± 25%), HIV RNA load (± 25%) and previous antiretroviral therapy exposure. Results: In 81.5% of the study patients, complete or partial responses were observed within a median of 8 weeks. Treatment-related side effects were predominantly confined to leukopenia (44.4% of patients) and mild-to-moderate liver enzyme elevation (22.3% of patients). Relative CD4+ T cell counts increased to a similar degree both in study patients and matched pairs (7% vs 6%, respectively), yet, absolute CD4+ T cell counts augmented considerably stronger in chemotherapy- naïve matched pairs than in the study patients. Conclusion: The simultaneous administration of HAART and liposomal doxorubicin is a safe and effective treatment approach for advanced KS and HAART-mediated recovery of relative CD4+ T cell counts does not seem to be impaired by concomitant treatment with liposomal doxorubicin. [ABSTRACT FROM AUTHOR]