drugset / Trial / NCT00002093
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.
RandomizedTreatment
Summary
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.
Timeline
- Start
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- Primary completion
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- Completion
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Publications
- Background Gill PS, Wernz J, Scadden DT, Cohen P, Mukwaya GM, von Roenn JH, Jacobs M, Kempin S, Silverberg I, Gonzales G, Rarick MU, Myers AM, Shepherd F, Sawka C, Pike MC, Ross ME. Randomized phase III trial of liposomal daunorubicin versus doxorubicin, bleomycin, and vincristine in AIDS-related Kaposi's sarcoma. J Clin Oncol. 1996 Aug;14(8):2353-64. doi: 10.1200/JCO.1996.14.8.2353.
- Background Savage GE, Gable C, Motte K, Dixon C, Becker R. A pharmacoeconomic analysis of Kaposi's sarcoma patients based on a clinical trial of ABV vs. DaunoXome. Int Conf AIDS. 1996 Jul 7-12;11(Program Supplement):32 (abstract no LBB6048)
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bleomycin | Unknown | — | — |
| Subject | Daunorubicin | Small molecule | — | — |
| Subject | Doxorubicin | Other / unclassified | — | — |
| Subject | Vincristine | Small molecule | — | — |