Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Abbott


Information provided by (Responsible Party)
Abbott
ClinicalTrials.gov Identifier
NCT00002366

First received: November 2, 1999
Last updated: February 19, 2009
Last Verified: February 2009
History of Changes
Purpose

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

Further study details as provided by Abbott:

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

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

Locations

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

Sponsors and Collaborators

Abbott
More Information

More Information


Responsible Party: Abbott  
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  

Keywords provided by Abbott:

Skin Neoplasms
Sarcoma, Kaposi
Acquired Immunodeficiency Syndrome
HIV Protease Inhibitors
Ritonavir

Additional relevant MeSH terms:
HIV Infections
Sarcoma
Sarcoma, Kaposi
Ritonavir

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.