Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT00308620
Status:
TERMINATED
Last Update Posted:
2020-06-04
First Post:
2006-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Investigating the Anti-Human Immunodeficiency Virus (HIV) & Anti-inflammatory Effect of Chloroquine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D018450', 'term': 'Disease Progression'}, {'id': 'D007249', 'term': 'Inflammation'}], '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': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C023676', 'term': 'chloroquine diphosphate'}, {'id': 'D002738', 'term': 'Chloroquine'}], 'ancestors': [{'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'boulw001@umn.edu', 'phone': '6126269546', 'title': 'David Boulware', 'organization': 'University of Minnesota'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Chloroquine 500mg', 'description': 'Chloroquine 500mg PO once daily x 8 weeks', 'otherNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo once daily for 8 weeks', 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Chloroquine 250mg', 'description': 'Chloroquine 250mg PO once daily x 8 weeks', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Death (non-related)', 'notes': 'Autopsy Report', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'HIV Viral Load Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chloroquine 250mg or 500mg', 'description': 'Chloroquine 250mg or 500mg orally once daily x 8 weeks. n=6 for 250mg; n=3 for 500mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo orally once daily for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-.083', 'spread': '.5', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '.1', 'groupId': 'OG001'}]}]}], 'paramType': 'LOG_MEAN', 'timeFrame': 'baseline and 8 weeks', 'description': 'HIV-1 viral load change between baseline and 8 weeks', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Immune Activation Assessed by Flow Cytometry Analysis From Baseline to 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chloroquine 250mg or 500mg', 'description': 'Chloroquine 500mg orally once daily x 8 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo orally once daily for 8 weeks'}], 'classes': [{'title': 'CD8 CD38+HLA-DR+', 'categories': [{'measurements': [{'value': '-2.5', 'groupId': 'OG000', 'lowerLimit': '-7', 'upperLimit': '2'}, {'value': '1.85', 'groupId': 'OG001', 'lowerLimit': '-3', 'upperLimit': '2'}]}]}, {'title': 'CD4 ki67+', 'categories': [{'measurements': [{'value': '-2.0', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '2'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '-0.5', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8 weeks', 'description': 'The Change in the percentages of CD38+ HLA-DR+ CD8 and CD4 memory T cells from baseline to 8 weeks.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of Chloroquine arms is pooled.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Chloroquine 500mg', 'description': 'Chloroquine 500mg PO once daily x 8 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo once daily for 8 weeks'}, {'id': 'FG002', 'title': 'Chloroquine 250mg', 'description': 'Chloroquine 250mg PO once daily x 8 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '2006-2008 recruitment of volunteers in HIV care but electing to not receive ART.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Chloroquine 500mg', 'description': 'Chloroquine 500mg PO once daily x 8 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo once daily for 8 weeks'}, {'id': 'BG002', 'title': 'Chloroquine 250mg', 'description': 'Chloroquine 250mg PO once daily x 8 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40', 'spread': '15', 'groupId': 'BG000'}, {'value': '34', 'spread': '5', 'groupId': 'BG001'}, {'value': '36', 'spread': '5', 'groupId': 'BG002'}, {'value': '36.5', 'spread': '8.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'Insufficient financial support; lack of efficacy for primary endpoint', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-02', 'studyFirstSubmitDate': '2006-03-27', 'resultsFirstSubmitDate': '2011-09-26', 'studyFirstSubmitQcDate': '2006-03-27', 'lastUpdatePostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-07-09', 'studyFirstPostDateStruct': {'date': '2006-03-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HIV Viral Load Change', 'timeFrame': 'baseline and 8 weeks', 'description': 'HIV-1 viral load change between baseline and 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in Immune Activation Assessed by Flow Cytometry Analysis From Baseline to 8 Weeks', 'timeFrame': '8 weeks', 'description': 'The Change in the percentages of CD38+ HLA-DR+ CD8 and CD4 memory T cells from baseline to 8 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'chloroquine', 'disease progression', 'inflammation', 'treatment naive'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '20844049', 'type': 'RESULT', 'citation': 'Murray SM, Down CM, Boulware DR, Stauffer WM, Cavert WP, Schacker TW, Brenchley JM, Douek DC. Reduction of immune activation with chloroquine therapy during chronic HIV infection. J Virol. 2010 Nov;84(22):12082-6. doi: 10.1128/JVI.01466-10. Epub 2010 Sep 15.'}], 'seeAlsoLinks': [{'url': 'http://cvp.umn.edu', 'label': 'University of Minnesota Clinical Virology Program'}]}, 'descriptionModule': {'briefSummary': 'Summary: Chloroquine is a medication that in laboratory settings has significant anti-HIV effects in HIV infected T-cells. Chloroquine has been used safely for over 60 years for malaria treatment and prevention, and it also has significant anti-inflammatory effects. No formal study of chloroquine has been performed in people with HIV infection. Chloroquine is used worldwide and is quite inexpensive outside of the United States. If shown to be effective, chloroquine could be a very important tool worldwide in delaying HIV disease progression which would extend the time period without needing anti-retroviral therapy. In countries where anti-retroviral therapy is not available, this could be very helpful.\n\nThis is an 8 week trial study requiring 3 study visits. Participants will be ask to take a once a day study medication (chloroquine or placebo) for 8 weeks and have three blood draws for CD4 counts, HIV viral loads, and other research tests. The visits are at study enrollment, 4 weeks, and 8 weeks.', 'detailedDescription': 'Summary:\n\nA phase I randomized, double-blind, placebo controlled trial to investigate the efficacy of chloroquine to decrease T-cell activation and decrease viral load in early HIV.\n\nScientific Rationale:\n\nChloroquine has in vivo direct anti-HIV effects and an anti-inflammatory effect. These properties may be beneficial in reducing viral burden and immune activation therefore delaying HIV disease progression.\n\nSample Size: 25\n\nLength of Study: 8 weeks, \\[enrollment + 2 follow up visits\\].\n\nIntervention:\n\n* Arm 1a: Chloroquine 250mg orally once daily for 8 weeks.\n* Arm 1b: Chloroquine 500mg orally once daily for 8 weeks.\n* Arm 2: Placebo once daily for 8 weeks.\n\nMeasurements:\n\n* Blood draws at weeks: 0, 4, and 8 weeks.\n* CD4, viral load measurements will be communicated to the referring provider (with subject consent).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-1 infected adults\n* CD4 count \\> 250 cells/mm3\n* Not presently receiving HIV antiretroviral therapy (\\> 6 months or naïve)\n* Viral load \\> 3000 RNA copies/mL (3.5 log)\n* No planned HIV anti-retroviral therapy for 8 weeks\n\nExclusion Criteria:\n\n* Prior retinal eye disease\n* CD4 \\< 250 cells/µL\n* Renal failure\n* Active malignancy\n* Corticosteroid therapy\n* Age \\< 18 or \\> 65 years'}, 'identificationModule': {'nctId': 'NCT00308620', 'briefTitle': 'Investigating the Anti-Human Immunodeficiency Virus (HIV) & Anti-inflammatory Effect of Chloroquine', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'A Randomized, Pilot Study of the Anti-Viral and Anti-Inflammatory Effects of Chloroquine in Early HIV Infection', 'orgStudyIdInfo': {'id': '0510M77007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chloroquine', 'description': 'Chloroquine 205mg or 500mg orally once daily (Results pooled)', 'interventionNames': ['Drug: chloroquine phosphate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo once daily for 8 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'chloroquine phosphate', 'type': 'DRUG', 'otherNames': ['Aralen'], 'description': '250mg or 500mg PO (by mouth) QDay', 'armGroupLabels': ['Chloroquine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo once daily for 8 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota ACTU', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'David R Boulware, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'Minnesota Medical Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}