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.

Inclusion 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).