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.

Study Overview
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Brief Summary
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To compare the toxicity profiles (severity and time to onset from initiation of therapy) between daunorubicin (liposomal) and combination chemotherapy with doxorubicin/bleomycin/vincristine (ABV), with both regimens administered in combination with antiretroviral therapy. To compare the duration of responses, response rates, and times to response.

Official Title
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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.

Conditions
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Sarcoma, Kaposi, HIV Infections

Intervention / Treatment
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* Drug: Daunorubicin (liposomal)
* Drug: Bleomycin sulfate
* Drug: Vincristine sulfate
* Drug: Doxorubicin hydrochloride


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Daunorubicin (liposomal)|nan|
|Drug: Bleomycin sulfate|nan|
|Drug: Vincristine sulfate|nan|
|Drug: Doxorubicin hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vincristine, Sarcoma, Kaposi, Liposomes, Doxorubicin, Acquired Immunodeficiency Syndrome, Bleomycin, Daunorubicin, Drug Carriers