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

September 19, 2013 updated by: Centro di Riferimento Oncologico - Aviano

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Aviano, Italy, 33081
        • Centro di Riferimento Oncologico - Aviano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Efficacy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro di Riferimento Oncologico - Aviano

Investigators

  • Study Chair: Umberto Tirelli, MD, Centro di Riferimento Oncologico - Aviano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1998

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

September 20, 2013

Last Update Submitted That Met QC Criteria

September 19, 2013

Last Verified

November 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066438
  • ITA-GICAT-POS2
  • EU-97019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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