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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00002366
First received: November 2, 1999
Last updated: February 19, 2009
Last verified: February 2009
  Purpose

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


Condition Intervention Phase
Sarcoma, Kaposi
HIV Infections
Drug: Ritonavir
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: A Phase II Safety and Activity Study of Ritonavir in the Treatment of HIV-Associated Cutaneous Kaposi's Sarcoma

Resource links provided by NLM:


Further study details as provided by Abbott:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002366

Locations
Australia
Saint Vincent's Hosp Med Centre
Sydney, Australia
Prince Henry's Hosp / Med Oncology
Sydney, Australia
Sponsors and Collaborators
Abbott
  More Information

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)

ClinicalTrials.gov Identifier: NCT00002366     History of Changes
Other Study ID Numbers: 245C, M95-320
Study First Received: November 2, 1999
Last Updated: February 19, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Skin Neoplasms
Sarcoma, Kaposi
Acquired Immunodeficiency Syndrome
HIV Protease Inhibitors
Ritonavir

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
Sarcoma
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
HIV Protease Inhibitors
Ritonavir
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014