Antiviral Therapy in Treating Patients With Slowly Progressing HIV-Related Kaposi's Sarcoma
- Conditions
- Sarcoma
- Registration Number
- NCT00003419
- Lead Sponsor
- Centro di Riferimento Oncologico - Aviano
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Centro di Riferimento Oncologico - Aviano
🇮🇹Aviano, Italy