NCT00002105

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (planned)
• Sponsor: Sequus Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the treatment of moderate to severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established therapy BV (bleomycin/vincristine). To evaluate the safety and tolerance of DOX-SL compared to BV in a population of AIDS patients with moderate to severe KS.

Detailed description

Patients are randomized to receive either DOX-SL or the BV combination. Infusions are given on day 1 and every 3 weeks for a total of six cycles. Kaposi's sarcoma lesions are evaluated prior to every cycle, at the end of the last treatment cycle, and 4 weeks following the end of the last treatment. Patients who respond to therapy will be followed every 2 months for up to 1 year. Patients must agree to have one or more representative KS lesions biopsied.

Conditions

• Sarcoma, Kaposi
• HIV Infections

Interventions

Type	Name	Description
DRUG	Doxorubicin hydrochloride (liposomal)
DRUG	Bleomycin sulfate
DRUG	Vincristine sulfate

Timeline

• First posted: 2001-08-31
• Last updated: 2005-06-24

Locations

4 sites across 1 country: United States