Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT00149656
Status:
COMPLETED
Last Update Posted:
2013-04-29
First Post:
2005-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Nutritional Supplementation and Drug Abuse on HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], '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': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C067316', 'term': 'Geritol'}, {'id': 'D012643', 'term': 'Selenium'}], 'ancestors': [{'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008903', 'term': 'Minerals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 878}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-26', 'studyFirstSubmitDate': '2005-09-06', 'studyFirstSubmitQcDate': '2005-09-06', 'lastUpdatePostDateStruct': {'date': '2013-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HIV Disease Progression', 'timeFrame': 'For at least 6 months'}], 'secondaryOutcomes': [{'measure': 'Morbidity', 'timeFrame': 'For at least 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Treatment Naive', 'Multivitamins', 'Selenium', 'Supplementation', 'HIV Disease Progression'], 'conditions': ['HIV Infections', 'Substance-Related Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to determine whether supplementation with multivitamins and selenium will delay disease progression in HIV infected individuals in Botswana. The study will also assess how drug abuse modifies the effect of nutritional supplementation on HIV disease progression.', 'detailedDescription': 'Botswana has the highest rates of HIV infection in the world. In addition, drug abuse has become an emerging problem in Botswana. Past research suggests that multivitamin and selenium supplementation slows the progression of HIV disease. The purpose of this trial is to evaluate the effectiveness of supplementation with multivitamins and selenium in HIV infected individuals in Botswana.\n\nThis trial will last 2 years. Participants will be randomly assigned to 4 groups: a combination of multivitamins with selenium, multivitamins alone, selenium alone, or placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV infected\n* CD4 count greater than 350 cells/mm3\n* Identified from the Infectious Disease Care Clinic\n* Body mass index greater than 18 for women and greater than 18.5 for men\n\nExclusion Criteria:\n\n* Current AIDS-defining condition\n* Currently participating in another clinical trial\n* Pregnant or intends to become pregnant during the study'}, 'identificationModule': {'nctId': 'NCT00149656', 'briefTitle': 'The Effects of Nutritional Supplementation and Drug Abuse on HIV', 'organization': {'class': 'OTHER', 'fullName': 'Florida International University'}, 'officialTitle': 'HIV Disease, Drug Abuse, and Nutrient Therapy in Botswana', 'orgStudyIdInfo': {'id': 'NIDA-16551-1'}, 'secondaryIdInfos': [{'id': 'R01DA016551', 'link': 'https://reporter.nih.gov/quickSearch/R01DA016551', 'type': 'NIH'}, {'id': 'R01-16551-1'}, {'id': 'DPMC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Multivitamins', 'interventionNames': ['Dietary Supplement: Multivitamins']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Multivitamins with Selenium', 'interventionNames': ['Dietary Supplement: Multivitamins', 'Dietary Supplement: Selenium']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'Selenium', 'interventionNames': ['Dietary Supplement: Selenium']}], 'interventions': [{'name': 'Multivitamins', 'type': 'DIETARY_SUPPLEMENT', 'description': 'dietary supplement of multivitamins', 'armGroupLabels': ['2', '3']}, {'name': 'Selenium', 'type': 'DIETARY_SUPPLEMENT', 'description': 'dietary supplement of selenium only', 'armGroupLabels': ['3', '4']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'placebo pill', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gaborone', 'country': 'Botswana', 'facility': 'Princess Marina Hospital', 'geoPoint': {'lat': -24.65451, 'lon': 25.90859}}], 'overallOfficials': [{'name': 'Marianna K. Baum, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Florida International University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida International University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}