Sarcoma Clinical Trial
Official title:
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.
;
Primary Purpose: Treatment
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