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

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002093 on ClinicalTrials.gov Archive Site
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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.
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
  • Sarcoma, Kaposi
  • HIV Infections
  • Drug: Daunorubicin (liposomal)
  • Drug: Bleomycin sulfate
  • Drug: Vincristine sulfate
  • Drug: Doxorubicin hydrochloride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002093
121A, 103-09
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Nexstar Pharmaceuticals
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NIH AIDS Clinical Trials Information Service
March 1996

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP