Activity of thalidomide in AIDS-related Kaposi's sarcoma and correlation with HHV8 titre

A phase II study of thalidomide was conducted to evaluate its efficacy and toxicity in the treatment of cutaneous AIDS-related Kaposi's sarcoma (AIDS- KS). To evaluate whether clinical response is correlated with titre of huma n herpesvirus 8 (HHV8) DNA in peripheral blood, levels were determined by s erial end-point dilution at enrolment and 4-6 weeks later. Seventeen male H IV-seropositive patients with histopathologically diagnosed KS were treated with thalidomide 100 mg orally once nightly for 8 weeks. Response evaluati on was performed using AIDS Clinical Trials Group (ACTG) criteria and analy sis was by intention to treat. Six of 17 patients achieved a partial response (35%: 95% confidence interva l 10-61%). Eight patients withdrew (6 owing to toxicity, one to early progr ession and one to non-compliance). HHV8 DNA load decreased by at least 3log (10) to undetectable levels in 3 of the 5 virologically assessable partial responders. This preliminary study demonstrates that thalidomide has activi ty in the treatment of AIDS-KS and that clinical response is associated wit h a reduction of HHV8 DNA titre in peripheral blood.