Treatment of HIV-Related Kaposi's Sarcoma and Stage I-III Slow-Proliferative Disease With Highly Active Antiretroviral Therapy (HAART)
antiviral therapy
Neoplasms+1
+ Neoplasms by Histologic Type
+ Neoplasms, Connective and Soft Tissue
Treatment Study
Summary
Study start date: June 1, 1998
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.25 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Centro di Riferimento Oncologico - Aviano
Aviano, ItalyOpen Centro di Riferimento Oncologico - Aviano in Google Maps