A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma

Phase 3

• Conditions: Sarcoma, Kaposi; HIV Infections

• Registration Number: NCT00002318
• Lead Sponsor: Sequus Pharmaceuticals

Brief Summary

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

Detailed Description

Patients are randomized to receive either DOX-SL or the ABV combination. Infusions are given on day 1 and every 2 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 must agree to have one or more representative KS lesions biopsied.

Study Timeline

• Status Verified: 1996-01
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (26)

East Bay AIDS Ctr; 🇺🇸 Berkeley, California, United States

Pacific Oaks Med Group; 🇺🇸 Sherman Oaks, California, United States

Hematology - Oncology Med Group of San Fernando Valley; 🇺🇸 Encino, California, United States

Dr Becky Miller; 🇺🇸 Los Angeles, California, United States

Apogee Med Group; 🇺🇸 San Diego, California, United States

UCSF - San Francisco Gen Hosp; 🇺🇸 San Francisco, California, United States

Kaiser Permanente Med Ctr; 🇺🇸 San Francisco, California, United States

UCSF; 🇺🇸 San Francisco, California, United States

San Francisco Veterans Administration Med Ctr; 🇺🇸 San Francisco, California, United States

Dr Mahmoud Mustafa; 🇺🇸 Washington, District of Columbia, United States

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