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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Treatment of HIV-Related Kaposi's Sarcoma and Stage I-III Slow-Proliferative Disease With Highly Active Antiretroviral Therapy (HAART)

Conditions
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Sarcoma

Intervention / Treatment
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* Procedure: antiviral therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: antiviral therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AIDS-related Kaposi sarcoma