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Sponsored by: |
Nexstar Pharmaceuticals |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002093 |
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.
Condition | Intervention | Phase |
---|---|---|
Sarcoma, Kaposi HIV Infections |
Drug: Daunorubicin (liposomal) Drug: Bleomycin sulfate Drug: Vincristine sulfate Drug: Doxorubicin hydrochloride |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | 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. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded within 7 days prior to study entry:
United States, Arizona | |
Univ of Arizona / Arizona Cancer Ctr | |
Tucson, Arizona, United States, 85724 | |
United States, California | |
Kenneth Norris Jr Cancer Hosp | |
Los Angeles, California, United States, 90033 | |
Saint Francis Mem Hosp | |
San Francisco, California, United States, 94109 | |
Desert Hosp Comprehensive Cancer Ctr | |
Palm Springs, California, United States, 92262 | |
Davies Med Ctr | |
San Francisco, California, United States, 94114 | |
United States, Colorado | |
Denver Gen Hosp | |
Denver, Colorado, United States, 802044507 | |
United States, District of Columbia | |
George Washington Univ Med Ctr | |
Washington, District of Columbia, United States, 20037 | |
United States, Florida | |
Univ of Miami Dept of Medicine | |
Miami, Florida, United States, 33136 | |
United States, Illinois | |
Northwestern Univ Med School | |
Chicago, Illinois, United States, 60611 | |
United States, Massachusetts | |
New England Deaconess Hosp | |
Boston, Massachusetts, United States, 02215 | |
United States, New York | |
New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
United States, Oregon | |
Kaiser Permanente Med Ctr | |
Portland, Oregon, United States, 97227 | |
United States, Texas | |
Dr Edward Stool | |
Houston, Texas, United States, 77004 |
Study ID Numbers: | 121A, 103-09 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002093 |
Health Authority: | United States: Food and Drug Administration |
Vincristine Sarcoma, Kaposi Liposomes Doxorubicin |
Acquired Immunodeficiency Syndrome Bleomycin Daunorubicin Drug Carriers |
Daunorubicin Sexually Transmitted Diseases, Viral Malignant mesenchymal tumor Acquired Immunodeficiency Syndrome Sarcoma, Kaposi Vincristine Bleomycin Doxorubicin Soft tissue sarcomas Immunologic Deficiency Syndromes |
Herpesviridae Infections Virus Diseases Neoplasms, Connective and Soft Tissue Kaposi sarcoma HIV Infections Sexually Transmitted Diseases Sarcoma DNA Virus Infections Retroviridae Infections |
RNA Virus Infections Slow Virus Diseases Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Mitosis Modulators Antimitotic Agents Infection |
Antibiotics, Antineoplastic Pharmacologic Actions Neoplasms Therapeutic Uses Tubulin Modulators Lentivirus Infections Neoplasms, Vascular Tissue Antineoplastic Agents, Phytogenic |