Clinical trial · Interventional
Treatment of Classical Non-HIV-Related Kaposi's Sarcoma With the Antiviral Drug Indinavir
A Phase II Trial With the HIV Protease Inhibitor Indinavir for the Treatment of Classical Kaposi's Sarcoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Classical Kaposi's Sarcoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| indinavir | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Assessment of clinical response every 3 months during treatment and every 6 months during follow-up based on the recommendations of ACTG.
Secondary outcomes (1)
- measure
- Monthly evaluation of toxicity and of biological endpoints every 3 months and their correlation with drug plasma levels
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDMonini P, Sgadari C, Toschi E, Barillari G, Ensoli B. Antitumour effects of antiretroviral therapy. Nat Rev Cancer. 2004 Nov;4(11):861-75. doi: 10.1038/nrc1479. PMID 15516959
- BACKGROUNDSgadari C, Barillari G, Toschi E, Carlei D, Bacigalupo I, Baccarini S, Palladino C, Leone P, Bugarini R, Malavasi L, Cafaro A, Falchi M, Valdembri D, Rezza G, Bussolino F, Monini P, Ensoli B. HIV protease inhibitors are potent anti-angiogenic molecules and promote regression of Kaposi sarcoma. Nat Med. 2002 Mar;8(3):225-32. doi: 10.1038/nm0302-225. PMID 11875492