Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma

Inclusion Criteria

• •Concurrent Medication:
• •Allowed:
• •Prophylaxis for PCP, cryptococcal, and herpes infections, and antiretroviral therapy (e.g., AZT, ddC, ddI) provided these doses have been stable for at least 1 month.
• •Maintenance therapy for tuberculosis, fungal, and herpes infections.
• •Therapy for new episodes of tuberculosis, fungal, and herpes infection except with potentially myelotoxic chemotherapy.
• •Foscarnet for cytomegalovirus infection.
• •Erythropoietin.
• •Patients must have:
• •Biopsy-proven, progressive, AIDS-related Kaposi's sarcoma, with any of the following:
• •At least 15 mucocutaneous lesions.
• •Six or more new lesions in the prior month.
• •Documented visceral disease with at least five accessible cutaneous lesions.
• •Documented anti-HIV antibody.
• •No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if REQUIRING treatment with myelotoxic drugs).
• •Life expectancy \> 4 months.
• •NOTE:
• •Patients who fail the BV combination or who relapse are eligible to enter the Liposome Technology open trial using DOX-SL alone.