Antiviral Therapy in Treating Patients With Slowly Progressing HIV-Related Kaposi's Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003419
Recruitment Status : Unknown
Verified November 2001 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : September 20, 2013
Information provided by:
National Cancer Institute (NCI)

November 1, 1999
January 27, 2003
September 20, 2013
June 1998
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Complete list of historical versions of study NCT00003419 on Archive Site
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Antiviral Therapy in Treating Patients With Slowly Progressing HIV-Related Kaposi's Sarcoma
Treatment of HIV-Related Kaposi's Sarcoma and Stage I-III Slow-Proliferative Disease With Highly Active Antiretroviral Therapy (HAART)

RATIONALE: HIV virus is found in the lesions of most patients with Kaposi's sarcoma, and may have a role in causing Kaposi's sarcoma. Antiviral therapy acts against the HIV virus and may be an effective treatment for Kaposi's sarcoma.

PURPOSE: This phase II trial is studying how well antiviral therapy works in treating patients with slowly progressing HIV-related Kaposi's sarcoma.


  • Determine the efficacy of highly active antiretroviral therapy (HAART) in treating patients with HIV-related stage I-III nonaggressive epidemic Kaposi's sarcoma.

OUTLINE: Patients receive therapy consisting of nucleoside analogues (RTI) and protease inhibitors (PI). Patients may receive either 2 RTIs or 2 RTIs plus 2 PIs. Treatment continues for 12 weeks, then progression is assessed.

Patients with stable or regressing Kaposi's sarcoma (KS) with a viral load of greater than 500 copies of RNA/mL may continue with the therapy (if the viral load has decreased by greater than 2 logs) or may modify therapy (if the viral load has decreased less than 2 logs). Patients with progressive disease may begin chemotherapy but continue to receive the antiretroviral therapy. Treatment continues for at least 48 weeks.

Patients are followed every 8 weeks until week 48.

PROJECTED ACCRUAL: This study will accrue a total of 14-25 patients.

Phase 2
Primary Purpose: Treatment
Procedure: antiviral therapy
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
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  • Stage I-III (NYU) Kaposi's sarcoma that is slowly progressive

    • Stable disease without progression in diameter of tumor or in number of lesions (less than 50% increase in 3 months)
    • No progressive disease during or after treatment for Kaposi's sarcoma
  • Level of viral load detectable independently from CD4+ cells
  • No other active AIDS pathologies



  • 18 and over

Performance status:

  • ECOG 0-3

Life expectancy:

  • Not specified


  • WBC greater than 1500/mm3
  • Hemoglobin greater than 8 mg/dL


  • Bilirubin less than 2.5 times normal
  • AST and ALT less than 5 times normal
  • Alkaline phosphatase less than 2.5 times normal


  • Creatinine less than 2.5 times normal


  • No prior malignancy except carcinoma in situ of the cervix or nonmelanomatous skin cancer
  • No active cytomegalovirus, herpes simplex 1 or 2, or herpes zoster infection requiring treatment


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified


  • No prior antiretroviral therapy OR
  • No prior highly active antiretroviral therapy (HAART)
  • No concurrent acyclovir, ganciclovir, foscarnet, or cidofovir
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Centro di Riferimento Oncologico - Aviano
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Study Chair: Umberto Tirelli, MD Centro di Riferimento Oncologico - Aviano
National Cancer Institute (NCI)
November 2001

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