Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT00002218
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase I Maximum Tolerated Dose Study of CI-1012 in Late-Stage HIV+ Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'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': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1998-07', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['HIV-1', 'Dose-Response Relationship, Drug', 'Anti-HIV Agents'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'To determine the maximum tolerated dose of CI-1012 in late-stage HIV-1-infected patients. To determine the antiretroviral activity of CI-1012 when added to combination therapy. To assess the multiple-dose pharmacokinetic characteristics of CT-1012 when added to combination therapy. To assess the effect of CI-1012 on the pharmacokinetics of other antiretroviral agents.', 'detailedDescription': 'Doses are escalated based on safety assessments: As soon as a dose meets the criteria for "tolerated" or "not tolerated", doses are escalated or terminated, respectively. All patients are treated for 2 weeks, with follow-up visits scheduled 1 week and 1 month post-treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nPatients must have:\n\n* Serological evidence of late-stage HIV-1 infection (ELISA and Western Blot).\n* CD4 T cell count less than or equal to 200 mm3.\n* HIV-1 RNA greater than or equal to 5,000 copies/mL.\n\nExclusion Criteria\n\nPrior Medication:\n\nExcluded:\n\n* Anti-HIV treatment within 8 weeks prior to entry.\n* Systemic steroids within 4 weeks prior to entry.\n\nPrior Treatment:\n\nExcluded:\n\nTreatment with anticancer agents within 4 weeks prior to study.'}, 'identificationModule': {'nctId': 'NCT00002218', 'briefTitle': 'A Phase I Maximum Tolerated Dose Study of CI-1012 in Late-Stage HIV+ Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'A Phase I Maximum Tolerated Dose Study of CI-1012 in Late-Stage HIV+ Patients', 'orgStudyIdInfo': {'id': '278B'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CI-1012', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'ViRx Inc', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '94109', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'ViRx Inc', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Central Florida Research Initiative', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Natl Institutes of Health', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Univ of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Univ of Utah Med School / Clinical Trials Ctr', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Parke-Davis', 'class': 'INDUSTRY'}}}}