Trials / Unknown
UnknownNCT00003419
Antiviral Therapy in Treating Patients With Slowly Progressing HIV-Related Kaposi's Sarcoma
Treatment of HIV-Related Kaposi's Sarcoma and Stage I-III Slow-Proliferative Disease With Highly Active Antiretroviral Therapy (HAART)
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- Sponsor
- Centro di Riferimento Oncologico - Aviano · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | antiviral therapy |
Timeline
- Start date
- 1998-06-01
- First posted
- 2003-01-27
- Last updated
- 2013-09-20
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT00003419. Inclusion in this directory is not an endorsement.