ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
The Safety and Effectiveness of Ritonavir in the Treatment of HIV-Related Kaposi's Sarcoma

This study has been completed.

Sponsored by: Abbott
Information provided by: NIH AIDS Clinical Trials Information Service
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

MedlinePlus related topics:   AIDS    Cancer    Kaposi's Sarcoma    Soft Tissue Sarcoma   

Drug Information available for:   Ritonavir   

U.S. FDA Resources

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
  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 antiretrovial 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
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002366
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Skin Neoplasms  
Sarcoma, Kaposi  
Acquired Immunodeficiency Syndrome  
HIV Protease Inhibitors  
Ritonavir  

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Malignant mesenchymal tumor
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
Skin Neoplasms
Soft tissue sarcomas
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
Neoplasms, Connective and Soft Tissue
Kaposi sarcoma
Ritonavir
HIV Infections
Sexually Transmitted Diseases
Sarcoma
DNA Virus Infections
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
HIV Protease Inhibitors
Anti-HIV Agents
Slow Virus Diseases
Neoplasms by Histologic Type
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Neoplasms
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Neoplasms, Vascular Tissue

ClinicalTrials.gov processed this record on December 03, 2008




Links to all studies - primarily for crawlers