Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-02 @ 7:34 AM
Study NCT ID:
NCT00397566
Status:
WITHDRAWN
Last Update Posted:
2012-04-27
First Post:
2006-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multiple Ascending Dose Study of BMS-707035 in HIV-1 Infected Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019429', 'term': 'Integrase Inhibitors'}, {'id': 'C000629780', 'term': 'BMS-707035'}], 'ancestors': [{'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-02'}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-26', 'studyFirstSubmitDate': '2006-11-08', 'studyFirstSubmitQcDate': '2006-11-08', 'lastUpdatePostDateStruct': {'date': '2012-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the antiviral activity of selected doses of BMS-707035 administered orally to HIV-1 infected subjects for 10 days.'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability with 10 days of dosing'}, {'measure': 'Effect on QTc intervals'}, {'measure': 'Effect on CD4+, CD8+, and CD8+CD38+ lymphocyte'}, {'measure': 'Pharmacokinetics of multiple doses of BMS-707035 in HIV-1 infected subjects'}, {'measure': 'Assess relationship of EC90 and exposures of BMS-707035 to the magnitude of change in viral loads'}, {'measure': 'Assess plasma protein binding and intracellular concentration in PBMC for BMS-707035'}]}, 'conditionsModule': {'keywords': ['HIV', 'Treatment Experienced'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical research study is to assess the safety, pharmacokinetics and pharmacodynamics of BMS-707035 in subjects infected with HIV-1'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-1-infected subjects with CD4+ lymphocyte count ≥ 200 cells/mm3 and with plasma HIV-1 RNA ≥ 5000 copies/mL who have not been on antiretroviral (ARV) therapy for ≥ 8 weeks or who are naive to ARV, and who are otherwise medically stable as determined by medical history, physical examination, 12 lead electrocardiogram, and clinical laboratory evaluations will be eligible to participate in the study. In addition, subjects must have had no prior exposure to the Integrase Inhibitor class of compounds.\n* Female subjects must not be nursing, pregnant, or of childbearing potential'}, 'identificationModule': {'nctId': 'NCT00397566', 'briefTitle': 'A Multiple Ascending Dose Study of BMS-707035 in HIV-1 Infected Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Randomized, Placebo-Controlled, Ascending Multiple Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-707035 in HIV-1 Infected Subjects', 'orgStudyIdInfo': {'id': 'AI441-008'}}, 'armsInterventionsModule': {'interventions': [{'name': 'HIV Integrase Inhibitor (BMS-707035)', 'type': 'DRUG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}}}}