Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2026-01-26 @ 9:22 PM
Study NCT ID:
NCT00981318
Status:
TERMINATED
Last Update Posted:
2015-06-23
First Post:
2009-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Assessment of Lopinavir/Ritonavir and Maraviroc
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], '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'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061466', 'term': 'Lopinavir'}, {'id': 'D019438', 'term': 'Ritonavir'}, {'id': 'D000077592', 'term': 'Maraviroc'}, {'id': 'C558899', 'term': 'lopinavir-ritonavir drug combination'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D014230', 'term': 'Triazoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'unable to enroll expected number of subjects', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-20', 'studyFirstSubmitDate': '2009-09-19', 'studyFirstSubmitQcDate': '2009-09-21', 'lastUpdatePostDateStruct': {'date': '2015-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Virologic response defined as viral load reduction of >/= 1 log', 'timeFrame': '48 weeks'}], 'secondaryOutcomes': [{'measure': 'Assess proportion of patients with HIV-1 viral load < 48 copies', 'timeFrame': '48 weks'}, {'measure': 'Assess time to loss of virologic response', 'timeFrame': '48 weeks'}, {'measure': 'Assess development of resistance mutations in patients who develop rebound', 'timeFrame': '48 weeks'}, {'measure': 'Compare serum lipid profile changes', 'timeFrame': '48 weeks'}, {'measure': 'Assess safety and tolerability', 'timeFrame': '48 weeks'}, {'measure': 'Assess degree of immune reconstitution', 'timeFrame': '48 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acquired Immunodeficiency Syndrome', 'HIV', 'AIDS', 'treatment experienced'], 'conditions': ['HIV Infections', 'Acquired Immunodeficiency Syndrome']}, 'descriptionModule': {'briefSummary': 'This is a study to assess the response of lopinavir/ritonavir plus maraviroc (with no nucleoside medications) in HIV patients failing their initial antiviral therapy.', 'detailedDescription': 'As long-term toxicity to many of the nucleoside medications have become known, interest has increased in treatment regimens that do not use these medications. This study is to assess the response of one such "nucleoside-sparing" therapy in patients who are showing failure to their initial nucleoside-containing treatment regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV viral load \\> 1,000 on current antiviral medications\n* No resistance to study medications\n* Over 18 years of age\n\nExclusion Criteria:\n\n* Hepatitis B co-infection\n* Pregnancy\n* Previous therapy with either of the study medications\n* Ongoing substance abuse\n* Significant history of other physical disease'}, 'identificationModule': {'nctId': 'NCT00981318', 'acronym': 'PALM', 'briefTitle': 'Pilot Assessment of Lopinavir/Ritonavir and Maraviroc', 'organization': {'class': 'INDIV', 'fullName': 'Rodwick, Barry M., M.D.'}, 'officialTitle': 'Pilot Assessment of Lopinavir/Ritonavir and Maraviroc in Experienced Patients', 'orgStudyIdInfo': {'id': 'Rodwick01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid', 'description': 'single arm', 'interventionNames': ['Drug: lopinavir/ritonavir plus maraviroc']}], 'interventions': [{'name': 'lopinavir/ritonavir plus maraviroc', 'type': 'DRUG', 'otherNames': ['Kaletra', 'lopinavir', 'Selzentry'], 'description': 'lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid', 'armGroupLabels': ['lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34695', 'city': 'Safety Harbor', 'state': 'Florida', 'country': 'United States', 'facility': 'Barry M. Rodwick, M. D.', 'geoPoint': {'lat': 27.99085, 'lon': -82.69316}}], 'overallOfficials': [{'name': 'Barry M. Rodwick, M. D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Barry M. Rodwick, M. D.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rodwick, Barry M., M.D.', 'class': 'INDIV'}, 'collaborators': [{'name': 'Abbott', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Barry M. Rodwick, M. D.', 'investigatorAffiliation': 'Rodwick, Barry M., M.D.'}}}}