Trial record 7 of 327 for:    Doxorubicin (liposomal) OR Doxil[TREATMENT] AND HIV [CONDITION]

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:
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
  Purpose

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:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

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).
  Contacts and Locations
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
  More Information

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
Doxorubicin
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
Vincristine
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on April 17, 2014