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

November 2, 1999
February 19, 2009
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Complete list of historical versions of study NCT00002366 on ClinicalTrials.gov Archive Site
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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.

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Interventional
Phase 2
Endpoint Classification: Safety Study
Primary Purpose: Treatment
  • Sarcoma, Kaposi
  • HIV Infections
Drug: Ritonavir
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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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00002366
245C, M95-320
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Abbott
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Abbott
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP