A Randomized Phase III Clinical Trial of Daunoxome Versus Combination Chemotherapy With Adriamycin/Bleomycin/Vincristine (ABV) in the Treatment of HIV-Associated Kaposi's Sarcoma.

Launched by NEXSTAR PHARMACEUTICALS · Aug 30, 2001

Keywords

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Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Patients must have:
• • HIV infection.
• • Advanced Kaposi's sarcoma.
• Prior Medication:
• Allowed:
• • Prior intralesional vinblastine.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms and conditions are excluded:
• • Acute intercurrent infection other than genital herpes.
• • Uncompensated cardiovascular, hepatic, renal, or pulmonary disease unrelated to Kaposi's sarcoma.
• • Symptomatic peripheral neuropathy.
• • Any condition that compromises ability to give informed consent or complete the study.
• Concurrent Medication:
• Excluded:
• • Concurrent ganciclovir.
• Patients with the following prior conditions are excluded:
• • Symptomatic AIDS-defining opportunistic infection within 2 weeks of entry.
• • History of malignancy other than Kaposi's sarcoma, basal cell carcinoma, or carcinoma in situ of the cervix.
• Prior Medication:
• Excluded:
• • Prior systemic chemotherapy.
• • Intralesional therapies within 7 days prior to study entry.
• • Growth factors (G-CSF or GM-CSF), immune modifiers, or investigational agents within 14 days prior to study entry.
• • Interferon preparations (alpha or beta) within 28 days prior to study entry.
• Prior Treatment:
• Excluded within 7 days prior to study entry:
• • Radiation.
• • Local therapies (e.g., cryotherapy).