The Safety and Effectiveness of Ritonavir in the Treatment of HIV-Related Kaposi's Sarcoma
Information provided by (Responsible Party)
First received: November 2, 1999
Last updated: February 19, 2009
Last Verified: February 2009
History of Changes
To evaluate the safety and anti-Kaposi's sarcoma activity of ritonavir.
Drug : Ritonavir
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:
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
- 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.
- 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.
- History of psychiatric illness which is currently medically significant.
- History of pancreatitis.
- 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.
Localized radiotherapy will be allowed for lesions which will not be used as indicator or biopsy lesions.
Patients must have:
Patients with the following symptoms and conditions are excluded:
Radiotherapy for Kaposi's sarcoma.
Patients with any of the following prior conditions are excluded:
Active substance abuse.
Contacts and LocationsChoosing 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 Show More
|Prince Henry's Hosp / Med Oncology|
|Saint Vincent's Hosp Med Centre|
Sponsors and CollaboratorsAbbott
|ClinicalTrials.gov Identifier:||NCT00002366 History of Changes|
|Other Study ID Numbers:||245C|
|Study First Received:||November 2, 1999|
|Last Updated:||February 19, 2009|
Keywords provided by Abbott:Skin Neoplasms
Acquired Immunodeficiency Syndrome
HIV Protease Inhibitors
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on July 19, 2018
This information is provided by ClinicalTrials.gov.