Antiviral Therapy in Treating Patients With Slowly Progressing HIV-Related Kaposi's Sarcoma
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 Design:||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)|
- Efficacy [ Designated as safety issue: No ]
|Study Start Date:||June 1998|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003419
|Centro di Riferimento Oncologico - Aviano|
|Aviano, Italy, 33081|
|Study Chair:||Umberto Tirelli, MD||Centro di Riferimento Oncologico - Aviano|