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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 History of Changes |
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 Acquired Immunodeficiency Syndrome Sarcoma, Kaposi Vincristine Antimitotic Agents Bleomycin Doxorubicin Immunologic Deficiency Syndromes Kaposi Sarcoma Herpesviridae Infections Virus Diseases |
Anti-Bacterial Agents Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Malignant Mesenchymal Tumor HIV Infections Tubulin Modulators Sexually Transmitted Diseases Sarcoma DNA Virus Infections Antineoplastic Agents, Phytogenic Retroviridae Infections |
Daunorubicin Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Infection Antibiotics, Antineoplastic Neoplasms, Connective and Soft Tissue Therapeutic Uses Neoplasms, Vascular Tissue Retroviridae Infections RNA Virus Infections Neoplasms by Histologic Type Immune System Diseases Mitosis Modulators |
Sarcoma, Kaposi Acquired Immunodeficiency Syndrome Vincristine Antimitotic Agents Bleomycin Pharmacologic Actions Immunologic Deficiency Syndromes Doxorubicin Herpesviridae Infections Virus Diseases Neoplasms HIV Infections Tubulin Modulators Sexually Transmitted Diseases Lentivirus Infections |