Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-27 @ 9:59 PM
Study NCT ID:
NCT00197561
Status:
COMPLETED
Last Update Posted:
2010-11-11
First Post:
2005-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Partnership on Nutrition and HIV/AIDS Research in Tanzania: Exploratory Research Study on Selenium and HIV Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'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': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 915}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-09', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2010-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in CD4 cell counts and viral load from baseline to six weeks and six months postpartum in HIV-1 positive women', 'timeFrame': 'Enrollment (12-27 wks gestation) to 6 months postpartum'}, {'measure': 'Risk of lower genital shedding of HIV-1 infected cells at 36 wks gestation', 'timeFrame': 'At 36 wks gestation'}], 'secondaryOutcomes': [{'measure': 'Risk of subclinical mastitis as defined by elevated sodium concentrations in breastmilk at 6 weeks postpartum', 'timeFrame': '6 weeks postpartum'}, {'measure': 'Fetal death, premature delivery, and low birth weight', 'timeFrame': 'Delivery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'Selenium', 'Nutrition', 'Women', 'Pregnancy', 'Tanzania', 'Maternal and child health outcomes', 'HIV/AIDS', 'Pregnancy Outcome'], 'conditions': ['HIV Infections', 'Pregnancy Complications']}, 'referencesModule': {'references': [{'pmid': '19368503', 'type': 'RESULT', 'citation': 'Kupka R, Mugusi F, Aboud S, Hertzmark E, Spiegelman D, Fawzi WW. Effect of selenium supplements on hemoglobin concentration and morbidity among HIV-1-infected Tanzanian women. Clin Infect Dis. 2009 May 15;48(10):1475-8. doi: 10.1086/598334.'}, {'pmid': '18541571', 'type': 'DERIVED', 'citation': 'Kupka R, Mugusi F, Aboud S, Msamanga GI, Finkelstein JL, Spiegelman D, Fawzi WW. Randomized, double-blind, placebo-controlled trial of selenium supplements among HIV-infected pregnant women in Tanzania: effects on maternal and child outcomes. Am J Clin Nutr. 2008 Jun;87(6):1802-8. doi: 10.1093/ajcn/87.6.1802.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the oral administration of daily selenium supplements to HIV-1 positive pregnant women: enhances immune status and reduces the HIV-1 viral load at six months postpartum, reduces the risk of lower genital shedding of HIV-1 infected cells at 36 weeks of gestation, and reduces the risk of mastitis at six weeks postpartum, compared to placebo.', 'detailedDescription': 'We are recruiting pregnant women who are infected with HIV and assign them to receive selenium or placebo. All women will be given standard prenatal care, including nevirapine for the prevention of mother-to-child transmission and prenatal multivitamin supplements. We will examine the effect of the selenium supplements on intermediate outcomes predictive of the risks of transmission of HIV and to disease progression.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-1 Infected women between 12 and 27 weeks of gestation\n\nExclusion Criteria:\n\n* Women with clinical AIDS defined according to WHO Criteria'}, 'identificationModule': {'nctId': 'NCT00197561', 'briefTitle': 'Partnership on Nutrition and HIV/AIDS Research in Tanzania: Exploratory Research Study on Selenium and HIV Infection', 'organization': {'class': 'OTHER', 'fullName': 'Harvard School of Public Health (HSPH)'}, 'officialTitle': 'Partnership on Nutrition and HIV/AIDS Research in Tanzania: Exploratory Research Study on Selenium and HIV Infection', 'orgStudyIdInfo': {'id': 'HD43555'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Selenium', 'description': 'Selenium (200 ug as selenomethionine)', 'interventionNames': ['Dietary Supplement: Selenium']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Taken orally once per day from randomization through delivery and through the first 6 months after delivery.', 'armGroupLabels': ['Placebo']}, {'name': 'Selenium', 'type': 'DIETARY_SUPPLEMENT', 'description': '200 ug of selenomethionine taken orally once per day from randomization through delivery and for the first 6 months after delivery', 'armGroupLabels': ['Selenium']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Upanga', 'state': 'Dar Es Salaaam', 'country': 'Tanzania', 'facility': 'Muhimibili University College of Health Scienes'}], 'overallOfficials': [{'name': 'Wafaie W. Fawzi, MD, DrPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard School of Public Health (HSPH)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Muhimbili University of Health and Allied Sciences', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Wafaie Fawzi', 'oldOrganization': 'Harvard School of Public Health'}}}}