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Status unknownNCT00003419Updated Sep 20, 2013

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

A Phase 2 interventional study of antiviral therapy in Sarcoma, sponsored by Centro di Riferimento Oncologico - Aviano. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-20.

Sponsored by Centro di Riferimento Oncologico - Aviano · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2001), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
25
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Sarcoma

Keywords

  • AIDS-related Kaposi sarcoma
03

In context

Sarcoma, Kaposi

162 studies on the registry are indexed under Sarcoma, Kaposi; 29 are open to participants now.

This study's planned enrollment of 25 is below the median of 32 across 114 interventional studies indexed under Sarcoma, Kaposi.

Browse Sarcoma, Kaposi studies →

Lead sponsor

Centro di Riferimento Oncologico - Aviano is the lead sponsor of 47 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Enrollment
25 participants (estimated)

Interventions

  • Procedureantiviral therapy
06

What researchers measure

Primary outcomes

  1. Efficacy

07

Study locations

1 site
  • Centro di Riferimento Oncologico - Aviano
    Aviano, 33081, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00003419
Lead sponsor
Centro di Riferimento Oncologico - Aviano
First posted
Jan 27, 2003
Start date
Jun 1998
Last update
Sep 20, 2013

Study contacts

Umberto Tirelli, MD
study chair · Centro di Riferimento Oncologico - Aviano
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2001. You cannot join it, but the record below documents what was studied.

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