Recently, two clinical trials demonstrated an antitumour effect of systemic high-dose beta-hCG therapy and of different regimens of local beta-hCG injections in AIDS-related Kaposi's sarcoma. We report the efficacy and safety of subcutaneous beta-hCG treatment (low-dose (2500-25000 IU/day) or high dose (25000-100000 IU/day)) in eight patients with advanced HIV disease in whom systemic chemotherapy and radiation were contraindicated or had failed. During therapy, serum hCG-concentrations as well as LH and FSH were measured. In the low-dose regimen one partial response was achieved. In the high-dose regimen, one patient maintained his response without further improvement. Three patients had stable disease and four patients disease progression. Serious side effects related to beta-hCG therapy were not observed. In conclusion, systemic beta-hCG-therapy for Kaposi's sarcoma is safe but associated with regression only in a minority of patients with advanced HIV-disease.