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The Safety and Effectiveness of Ritonavir in the Treatment of HIV-Related Kaposi's Sarcoma
This study has been completed.
First Received: November 2, 1999   Last Updated: February 19, 2009   History of Changes
Sponsored by: Abbott
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00002366
  Purpose

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


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

Study Type: Interventional
Study Design: Treatment, Safety Study
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:

  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)

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

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

Study placed in the following topic categories:
Anti-Infective Agents
HIV Protease Inhibitors
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
Skin Neoplasms
Antiviral Agents
Immunologic Deficiency Syndromes
Protease Inhibitors
Kaposi Sarcoma
Herpesviridae Infections
Virus Diseases
Neoplasms, Connective and Soft Tissue
Soft Tissue Sarcomas
Malignant Mesenchymal Tumor
Anti-Retroviral Agents
Ritonavir
HIV Infections
Sexually Transmitted Diseases
Sarcoma
DNA Virus Infections
Retroviridae Infections

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

ClinicalTrials.gov processed this record on September 01, 2009