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.
This study has been completed.
Sponsor:
Nexstar Pharmaceuticals
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002093
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 1996
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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.
Condition | Intervention | Phase |
---|---|---|
Sarcoma, Kaposi HIV Infections |
Drug: Daunorubicin (liposomal) Drug: Bleomycin sulfate Drug: Vincristine sulfate Drug: Doxorubicin hydrochloride |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Primary Purpose: Treatment |
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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Vincristine sulfate
Bleomycin
Daunorubicin
Doxorubicin
Daunorubicin hydrochloride
Doxorubicin hydrochloride
U.S. FDA Resources
Further study details as provided by NIH AIDS Clinical Trials Information Service:
![](https://webarchive.library.unt.edu/web/20130225131314im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
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).
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002093
Locations
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 | |
Desert Hosp Comprehensive Cancer Ctr | |
Palm Springs, California, United States, 92262 | |
Davies Med Ctr | |
San Francisco, California, United States, 94114 | |
Saint Francis Mem Hosp | |
San Francisco, California, United States, 94109 | |
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 |
Sponsors and Collaborators
Nexstar Pharmaceuticals
![](https://webarchive.library.unt.edu/web/20130225131314im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Publications:
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)
ClinicalTrials.gov Identifier: | NCT00002093 History of Changes |
Other Study ID Numbers: | 121A, 103-09 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
Vincristine Sarcoma, Kaposi Liposomes Doxorubicin |
Acquired Immunodeficiency Syndrome Bleomycin Daunorubicin Drug Carriers |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Sarcoma, Kaposi Sarcoma Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Herpesviridae Infections DNA Virus Infections |
Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Vascular Tissue Bleomycin Daunorubicin Doxorubicin Vincristine Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators |
ClinicalTrials.gov processed this record on February 21, 2013