Treatment of Classical Non-HIV-Related Kaposi's Sarcoma With the Antiviral Drug Indinavir

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Recent studies have described a reduced incidence or the regression of Kaposi's sarcoma (KS) in HIV-infected patients treated with the highly active anti-retroviral therapy (HAART) that contains at least one inhibitor of the HIV protease (HIV-PI) such as Indinavir. Experimental studies have shown that part of the anti-KS actions of HIV-PI are not related to their antiretroviral actions, but, at least in part, to their capability of blocking angiogenesis and tumor growth.

This study will be conducted on HIV-negative (classical) KS patients to prove that Indinavir has anti-angiogenic and anti-KS effects in humans independently of its antiretroviral activity.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istituto Superiore di Sanità
• Treatments: HIV Protease Inhibitors; Indinavir; Protease Inhibitors

Criteria

Inclusion Criteria:

• Have a documented diagnosis of classical KS

• Be HIV-negative

• Be 18 years old and over

• Have one or more of the following: a minimum of 3 measurable progressive lesions; all stages of complicated KS, i.e. showing functional impotency of the affected limbs, lymphedema, lymphorrea or pain; visceral disease; lack of response to conventional therapy (radiotherapy, chemotherapy); contraindication to conventional therapies-

Exclusion Criteria:

• Presence of life-threatening lesions or other concomitant illness, neoplasia or any other clinical condition threatening the health of the patient or his compliance to the treatment

• Inability to provide informed consent

• Concomitant treatment (within 30 days of initiating study treatment) with systemic immunomodulatory agents (e.g., glucocorticoids as immunosuppressive agents, interferons) or chemotherapy

• Pregnancy

• Impaired clinical conditions (Karnofsky's index <60

• Diabetes, history of nephrolithiasis or monolateral nephropathy

• Difficulty swallowing capsules/tablets

• Any clinically significant laboratory findings obtained during screening, including:

• Alkaline phosphatase (AP) >2 fold upper limit of normal (ULN)

• Aspartate aminotransferase (AST)

• Alkaline aminotransferase (ALT)

• Gamma-glutamyl transferase (gamma-GT) or total bilirubin >3 fold the ULN

• Serum creatinine >1.2 mg/d for women and >1.4 mg/dL for men or creatinine clearance > 100 +/- 25

• Pancreatic amylase >1.5 folds ULN

• Hemoglobin <10.0 g/dL for males, <9.0 g/dL for females

• Platelet count <75.000/cubic millimeter (mm3)

• Neutrophil count <850/mm3