The Safety and Effectiveness of Ritonavir in the Treatment of HIV-Related Kaposi's Sarcoma

A Phase II Safety and Activity Study of Ritonavir in the Treatment of HIV-Associated Cutaneous Kaposi's Sarcoma

To evaluate the safety and anti-Kaposi's sarcoma activity of ritonavir.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Sarcoma, Kaposi
• Intervention / Treatment: Drug: Ritonavir

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Sydney, Australia
    • Saint Vincent's Hosp Med Centre
  • Sydney, Australia
    • Prince Henry's Hosp / Med Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

Concurrent Medication:

Allowed:

• Patients may receive oral acyclovir and may continue prophylactic treatment for PCP, fungal infection, MAC and toxoplasmosis.
• Topical treatment and intralesional chemotherapy will be allowed for lesions which will not be used as indicator or biopsy lesions.

Concurrent Treatment:

Allowed:

Localized radiotherapy will be allowed for lesions which will not be used as indicator or biopsy lesions.

Patients must have:

• Documentation of a positive ELISA test for HIV with a confirmatory test.
• Biopsy proven, cutaneous or oropharyngeal Kaposi's sarcoma.
• Vital signs, physical examination and laboratory assessments that exhibit no evidence of an acute illness.
• Patients must agree to report all current medications to the primary investigator and obtain prior permission to use them when feasible.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

• Evidence of pulmonary Kaposi's sarcoma.
• Positive urine screen for recreational drugs.
• Current participation in another antiviral research study.
• Investigator anticipates poor patient compliance with the protocol.
• Patient has any condition that, in the investigator's opinion, may obscure the proper observation of the safety or activity of ritonavir.

Concurrent Medication:

Excluded:

• Antiretroviral therapy.
• Protease inhibitor therapy.
• Antiviral agent (e.g., oral ganciclovir or Foscarnet) or prophylactic medication for an AIDS defining illness which the patient cannot be removed from.
• Chemotherapy for Kaposi's sarcoma.
• Treatment with any medications that may interact with ritonavir.

Concurrent Treatment:

Excluded:

Radiotherapy for Kaposi's sarcoma.

Patients with any of the following prior conditions are excluded:

• History of psychiatric illness which is currently medically significant.
• History of pancreatitis.

Prior Medication:

Excluded:

• All antiretroviral therapy within 2 weeks prior to the start of the treatment phase of the study.
• Systemic chemotherapy of interferon within 30 days prior to study entry.
• Previous treatment with a protease inhibitor.

Risk Behavior:

Excluded:

Active substance abuse.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: Abbott

Publications and helpful links

General Publications

• Carr A, Milliken S, Lewis C, Mitsuyasu R, Miles S, Newell M, Cooper DA. A pilot phase II safety and activity study of ritonavir in the treatment of HIV-associated cutaneous Kaposi's sarcoma. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:194 (abstract no 703)

Study record dates

Study Registration Dates

• First Submitted: November 2, 1999
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Estimate): February 20, 2009
• Last Update Submitted That Met QC Criteria: February 19, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: Acquired Immunodeficiency Syndrome; HIV Protease Inhibitors; Ritonavir; Skin Neoplasms; Sarcoma, Kaposi
• Additional Relevant MeSH Terms: Virus Diseases; Infections; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; DNA Virus Infections; Herpesviridae Infections; Neoplasms, Vascular Tissue; Sarcoma; Sarcoma, Kaposi; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Ritonavir
• Other Study ID Numbers: 245C; M95-320