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

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).