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

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

 
Phase II
Interventional
Treatment, Safety Study
  • Sarcoma, Kaposi
  • HIV Infections
Drug: Ritonavir
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Abbott
 
 
Abbott
February 2009

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