Antiviral Therapy in Treating Patients With Slowly Progressing HIV-Related Kaposi's Sarcoma
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ClinicalTrials.gov 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
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sarcoma | Procedure: antiviral therapy | Phase 2 |
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 (Clinical Trial) |
Estimated Enrollment : | 25 participants |
Primary Purpose: | Treatment |
Official Title: | Treatment of HIV-Related Kaposi's Sarcoma and Stage I-III Slow-Proliferative Disease With Highly Active Antiretroviral Therapy (HAART) |
Study Start Date : | June 1998 |
- Efficacy

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003419
Italy | |
Centro di Riferimento Oncologico - Aviano | |
Aviano, Italy, 33081 |
Study Chair: | Umberto Tirelli, MD | Centro di Riferimento Oncologico - Aviano |
ClinicalTrials.gov Identifier: | NCT00003419 History of Changes |
Other Study ID Numbers: |
CDR0000066438 ITA-GICAT-POS2 EU-97019 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | September 20, 2013 |
Last Verified: | November 2001 |
Keywords provided by National Cancer Institute (NCI):
AIDS-related Kaposi sarcoma |
Additional relevant MeSH terms:
Sarcoma Sarcoma, Kaposi Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Herpesviridae Infections |
DNA Virus Infections Virus Diseases Neoplasms, Vascular Tissue Antiviral Agents Anti-Infective Agents |