Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2026-01-02 @ 9:28 AM
Study NCT ID:
NCT00002366
Status:
COMPLETED
Last Update Posted:
2009-02-20
First Post:
1999-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Safety and Effectiveness of Ritonavir in the Treatment of HIV-Related Kaposi's Sarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012514', 'term': 'Sarcoma, Kaposi'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019438', 'term': 'Ritonavir'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'lastUpdateSubmitDate': '2009-02-19', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2009-02-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Skin Neoplasms', 'Sarcoma, Kaposi', 'Acquired Immunodeficiency Syndrome', 'HIV Protease Inhibitors', 'Ritonavir'], 'conditions': ['Sarcoma, Kaposi', 'HIV Infections']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': "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)"}]}, 'descriptionModule': {'briefSummary': "To evaluate the safety and anti-Kaposi's sarcoma activity of ritonavir."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Patients may receive oral acyclovir and may continue prophylactic treatment for PCP, fungal infection, MAC and toxoplasmosis.\n* Topical treatment and intralesional chemotherapy will be allowed for lesions which will not be used as indicator or biopsy lesions.\n\nConcurrent Treatment:\n\nAllowed:\n\nLocalized radiotherapy will be allowed for lesions which will not be used as indicator or biopsy lesions.\n\nPatients must have:\n\n* Documentation of a positive ELISA test for HIV with a confirmatory test.\n* Biopsy proven, cutaneous or oropharyngeal Kaposi's sarcoma.\n* Vital signs, physical examination and laboratory assessments that exhibit no evidence of an acute illness.\n* Patients must agree to report all current medications to the primary investigator and obtain prior permission to use them when feasible.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms and conditions are excluded:\n\n* Evidence of pulmonary Kaposi's sarcoma.\n* Positive urine screen for recreational drugs.\n* Current participation in another antiviral research study.\n* Investigator anticipates poor patient compliance with the protocol.\n* Patient has any condition that, in the investigator's opinion, may obscure the proper observation of the safety or activity of ritonavir.\n\nConcurrent Medication:\n\nExcluded:\n\n* Antiretroviral therapy.\n* Protease inhibitor therapy.\n* Antiviral agent (e.g., oral ganciclovir or Foscarnet) or prophylactic medication for an AIDS defining illness which the patient cannot be removed from.\n* Chemotherapy for Kaposi's sarcoma.\n* Treatment with any medications that may interact with ritonavir.\n\nConcurrent Treatment:\n\nExcluded:\n\nRadiotherapy for Kaposi's sarcoma.\n\nPatients with any of the following prior conditions are excluded:\n\n* History of psychiatric illness which is currently medically significant.\n* History of pancreatitis.\n\nPrior Medication:\n\nExcluded:\n\n* All antiretroviral therapy within 2 weeks prior to the start of the treatment phase of the study.\n* Systemic chemotherapy of interferon within 30 days prior to study entry.\n* Previous treatment with a protease inhibitor.\n\nRisk Behavior:\n\nExcluded:\n\nActive substance abuse."}, 'identificationModule': {'nctId': 'NCT00002366', 'briefTitle': "The Safety and Effectiveness of Ritonavir in the Treatment of HIV-Related Kaposi's Sarcoma", 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': "A Phase II Safety and Activity Study of Ritonavir in the Treatment of HIV-Associated Cutaneous Kaposi's Sarcoma", 'orgStudyIdInfo': {'id': '245C'}, 'secondaryIdInfos': [{'id': 'M95-320'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Ritonavir', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sydney', 'country': 'Australia', 'facility': "Prince Henry's Hosp / Med Oncology", 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'city': 'Sydney', 'country': 'Australia', 'facility': "Saint Vincent's Hosp Med Centre", 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}}}}