NCT00362310

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2003

Typical duration for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

April 14, 2008

Status Verified

April 1, 2008

First QC Date

August 9, 2006

Last Update Submit

April 11, 2008

Conditions

Classical Kaposi's Sarcoma

Keywords

classical kaposi's sarcomatreatmentHIV protease inhibitor indinavir

Outcome Measures

Primary Outcomes (1)

  • 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)

  • Monthly evaluation of toxicity and of biological endpoints every 3 months and their correlation with drug plasma levels

Interventions

indinavirDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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-

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Centro di Riferimento Oncologico (CRO),

Aviano, Italy

Location

Department of Internal Medicine, University of Cagliari

Cagliari, Italy

Location

Dermatologic Clinic, Ospedale S. Anna

Ferrara, Italy

Location

Ospedale Maggiore, Mangiagalli e Regina Elena, IRCCS,

Milan, Italy

Location

Ospedale Civico Benfratelli

Palermo, Italy

Location

Department of Dermatological/Venereal Diseases and Plastic Surgery, University "La Sapienza"

Rome, Italy

Location

Istituto Dermatologico S. Gallicano-IRCCS

Rome, Italy

Location

Istituto Dermopatico dell'Immacolata-IRCCS (IDI)

Rome, Italy

Location

Dermatology Clinic, University of Sassari

Sassari, Italy

Location

Related Publications (2)

  • Monini 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: 15516959BACKGROUND

  • Sgadari 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: 11875492BACKGROUND

MeSH Terms

Interventions

Indinavir

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Barbara Ensoli, MD, PhD

    National AIDS Center, Istituto Superiore di Sanità, Rome, Italy

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 9, 2006

First Posted

August 10, 2006

Study Start

June 1, 2003

Study Completion

July 1, 2007

Last Updated

April 14, 2008

Record last verified: 2008-04

Locations

IT(9)