Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-31 @ 10:48 AM
Study NCT ID:
NCT01204905
Status:
COMPLETED
Last Update Posted:
2022-11-14
First Post:
2010-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
R5 Integrase Study in HIV-1 Naive Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D000068898', 'term': 'Raltegravir Potassium'}, {'id': 'D000077592', 'term': 'Maraviroc'}], 'ancestors': [{'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gbrogden@ihv.umaryland.edu', 'phone': '410-706-1660', 'title': 'Gregory Brogden', 'organization': 'University of Maryland, Baltimore, IHV'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '48 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Open Label ART', 'description': 'Patients received raltegravir 400 mg PO BID and maraviroc 300 mg PO BID in combination for 48 weeks.\n\nRaltegravir and Maraviroc in combination: Raltegravir 400 mg tablet twice a day, \\~12 hours (10 to 14 hours) apart\n\nMaraviroc 300 mg tablet twice a day, \\~12 hours (10 to 14 hours) apart', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 6, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Fatigue', 'notes': 'Fatigue resolved', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Light headedness', 'notes': 'Resolved', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mouth ulcers', 'notes': 'Resolved', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dental Infection', 'notes': 'Treatment Resolved', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncopal Episode', 'notes': 'Dehydration, resolved', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney Stones', 'notes': 'Treatment resolved', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Thrombocytopenia', 'notes': 'Not study related, Adverse Event occurred before study drug started.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gunshot Wound', 'notes': 'Not study related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label ART', 'description': 'Patients received raltegravir 400 mg PO BID and maraviroc 300 mg PO BID in combination for 48 weeks.\n\nRaltegravir and Maraviroc in combination: Raltegravir 400 mg tablet twice a day, \\~12 hours (10 to 14 hours) apart\n\nMaraviroc 300 mg tablet twice a day, \\~12 hours (10 to 14 hours) apart'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'This was a pilot study with a small sample population. There were no power calculations performed.', 'otherAnalysisDescription': 'The percentage of patients with HIV-1 viral loads less than 50 c/ml at 48 weeks.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 weeks', 'description': 'Percentage of subjects with HIV-1 viral load \\< 50 copies/ml', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Viral Suppression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label ART', 'description': 'Patients received raltegravir 400 mg PO BID and maraviroc 300 mg PO BID in combination for 48 weeks.\n\nRaltegravir and Maraviroc in combination: Raltegravir 400 mg tablet twice a day, \\~12 hours (10 to 14 hours) apart\n\nMaraviroc 300 mg tablet twice a day, \\~12 hours (10 to 14 hours) apart'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'There were no power calculations performed due to the size of the pilot study.', 'otherAnalysisDescription': 'Number of weeks to virologic suppression'}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks', 'description': 'Time to attainment of virologic suppression', 'unitOfMeasure': 'weeks', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Open Label ART', 'description': 'Patients received raltegravir 400 mg PO BID and maraviroc 300 mg PO BID in combination for 48 weeks.\n\nRaltegravir and Maraviroc in combination: Raltegravir 400 mg tablet twice a day, \\~12 hours (10 to 14 hours) apart\n\nMaraviroc 300 mg tablet twice a day, \\~12 hours (10 to 14 hours) apart'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Open Label ART', 'description': 'Patients received raltegravir 400 mg PO BID and maraviroc 300 mg PO BID in combination for 48 weeks.\n\nRaltegravir and Maraviroc in combination: Raltegravir 400 mg tablet twice a day, \\~12 hours (10 to 14 hours) apart\n\nMaraviroc 300 mg tablet twice a day, \\~12 hours (10 to 14 hours) apart'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '61'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single arm treatment study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2014-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-09', 'studyFirstSubmitDate': '2010-09-16', 'resultsFirstSubmitDate': '2018-07-12', 'studyFirstSubmitQcDate': '2010-09-16', 'lastUpdatePostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-20', 'studyFirstPostDateStruct': {'date': '2010-09-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Viral Load', 'timeFrame': '48 weeks', 'description': 'Percentage of subjects with HIV-1 viral load \\< 50 copies/ml'}], 'secondaryOutcomes': [{'measure': 'Viral Suppression', 'timeFrame': '48 weeks', 'description': 'Time to attainment of virologic suppression'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV-1', 'CD4', 'Viral Load', 'Human Immunodeficiency Virus (HIV)'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'This is a pilot, open-label study of raltegravir and maraviroc in combination for the treatment of antiretroviral naïve patients. The study will enroll 7 antiretroviral naïve patients with CD4 counts ≥ 350 and viral loads \\> 5,000. The subjects will be followed for 48 weeks. The combination of these two agents has the potential to be a potent regimen with minimal metabolic complications. However, they have not been studied in combination previously.\n\nThis pilot study proposes to evaluate this combination in antiretroviral naïve patients to document the safety and efficacy of this combination in order to provide clinicians with a treatment regimen that minimizes the risk of metabolic complications.', 'detailedDescription': 'Seven antiretroviral naïve HIV infected participants will be treated with a combination of raltegravir and maraviroc and followed for 48 weeks to determine the time to virologic suppression of (HIV-1 viral load \\< 50 copies/ml).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* HIV-1 infection\n* CD4 count ≥ 350\n* RNA \\> 5,000\n* CCR5 tropic virus\n* Baseline genotype without significant mutations known to confer antiretroviral drug resistance to currently licensed antiretroviral agents\n* Antiretroviral naïve (\\< 7 days of experience)\n* 18-75 years of age\n* Subject able to provide informed consent for the study\n* Women of child-bearing age agree to remain abstinent or use (or have their partner use) an acceptable method of birth control throughout the study. Acceptable method of birth control is defined as intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy.\n\nExclusion Criteria:\n\n* Dual/mixed tropic virus,\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>2.5 times the upper limits of normal;\n* Total bilirubin \\>1.5 mg/dL,\n* Women pregnant or breastfeeding,\n* History of malignancy\n* Enrollment in an experimental protocol with concomitant use of drugs known to impact or be impacted in terms of pk or drug-drug interactions with either raltegravir or maraviroc. This includes inducers of UGT1A1 ( such as rifampin, phenytoin, Phenobarbital rifabutin, St. John's wart) as well as CYP3A inhibitors (such as ketoconazole, itraconazole, clarithromycin , nefazodone and telithromycin) and CYP3A inducers (such as rifampin, carbamazepine, Phenobarbital and phenytoin)\n* Enrollment in an experimental protocol having received investigational agents(antiretroviral or non-antiretroviral) within 30 days of study enrollment\n* Chronic active hepatitis B infection\n* Subject has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the patient's participation for the full duration of the study, such that it is not in the best interest of the patient to participate.\n* Subject is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.\n* Subject requires or is anticipated to require any of the prohibited medications noted in the protocol"}, 'identificationModule': {'nctId': 'NCT01204905', 'briefTitle': 'R5 Integrase Study in HIV-1 Naive Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Raltegravir and Maraviroc in Combination for the Treatment of Antiretroviral Naïve HIV-1 Infected Patients', 'orgStudyIdInfo': {'id': 'HP-00045769'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open Label ART', 'description': 'Patients received raltegravir 400 mg PO BID and maraviroc 300 mg PO BID in combination for 48 weeks.', 'interventionNames': ['Drug: Raltegravir and Maraviroc in combination']}], 'interventions': [{'name': 'Raltegravir and Maraviroc in combination', 'type': 'DRUG', 'otherNames': ['Raltegravir (Isentress)', 'Maraviroc(Selzentry)'], 'description': 'Raltegravir 400 mg tablet twice a day, \\~12 hours (10 to 14 hours) apart\n\nMaraviroc 300 mg tablet twice a day, \\~12 hours (10 to 14 hours) apart', 'armGroupLabels': ['Open Label ART']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland, Institute of Human Virology', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Robert R. Redfield, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland, Institute of Human Virology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}