Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma
NCT00002105 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220
Last updated 2005-06-24
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.
Conditions
- Sarcoma, Kaposi
- HIV Infections
Interventions
- DRUG
-
Doxorubicin hydrochloride (liposomal)
- DRUG
-
Bleomycin sulfate
- DRUG
-
Vincristine sulfate
Sponsors & Collaborators
-
Sequus Pharmaceuticals
lead INDUSTRY
Study Design
- Purpose
- TREATMENT
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- United States
Study Locations
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