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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2001 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003419
First received: November 1, 1999
Last updated: September 19, 2013
Last verified: November 2001

November 1, 1999
September 19, 2013
June 1998
Not Provided
Efficacy [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00003419 on ClinicalTrials.gov 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.

OBJECTIVES:

  • 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.

Interventional
Phase 2
Primary Purpose: Treatment
Sarcoma
Procedure: antiviral therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25
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DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-3

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

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

Renal:

  • Creatinine less than 2.5 times normal

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other

  • No prior antiretroviral therapy OR
  • No prior highly active antiretroviral therapy (HAART)
  • No concurrent acyclovir, ganciclovir, foscarnet, or cidofovir
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00003419
CDR0000066438, ITA-GICAT-POS2, EU-97019
Not Provided
Not Provided
Centro di Riferimento Oncologico - Aviano
Not Provided
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