Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-02-25 @ 5:51 PM
Study NCT ID:
NCT02527005
Status:
COMPLETED
Last Update Posted:
2017-12-11
First Post:
2015-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Study of Azithromycin and S-P as Prophylaxis in Pregnant HIV+ Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008288', 'term': 'Malaria'}, {'id': 'D006679', 'term': 'HIV Seropositivity'}], 'ancestors': [{'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C001205', 'term': 'fanasil, pyrimethamine drug combination'}, {'id': 'D017963', 'term': 'Azithromycin'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-07', 'studyFirstSubmitDate': '2015-08-14', 'studyFirstSubmitQcDate': '2015-08-17', 'lastUpdatePostDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of malaria parasitemia at delivery in HIV positive women following administration of Azithromycin or Sulphadoxine- pyrimethamine as intermittent preventive therapy for malaria in pregnancy', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['IPT', 'malaria', 'pregnant', 'HIV positive'], 'conditions': ['Malaria', 'Pregnant', 'HIV']}, 'referencesModule': {'references': [{'pmid': '10028075', 'type': 'BACKGROUND', 'citation': 'Taylor WR, Richie TL, Fryauff DJ, Picarima H, Ohrt C, Tang D, Braitman D, Murphy GS, Widjaja H, Tjitra E, Ganjar A, Jones TR, Basri H, Berman J. Malaria prophylaxis using azithromycin: a double-blind, placebo-controlled trial in Irian Jaya, Indonesia. Clin Infect Dis. 1999 Jan;28(1):74-81. doi: 10.1086/515071.'}, {'pmid': '39324693', 'type': 'DERIVED', 'citation': 'Pons-Duran C, Wassenaar MJ, Yovo KE, Marin-Carballo C, Briand V, Gonzalez R. Intermittent preventive treatment regimens for malaria in HIV-positive pregnant women. Cochrane Database Syst Rev. 2024 Sep 26;9(9):CD006689. doi: 10.1002/14651858.CD006689.pub3.'}]}, 'descriptionModule': {'briefSummary': 'Randomized controlled single blind prospective comparative study', 'detailedDescription': 'This study is intended to be a randomized controlled single blind prospective comparative study conducted to compare the efficacy of three monthly doses of sulphadoxine-pyrimethamine as intermittent preventive therapy for malaria with azithromycin in HIV positive pregnant women'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant HIV positive patients,\n* Gestational age 16 weeks and above,\n* No history of azithromycin or sulphadoxine-pyrimethamine use four weeks prior to recruitment\n\nExclusion Criteria:\n\n* Anaemia packed cell volume less than 30%,\n* pre-existing medical conditions- diabetes mellitus,\n* hypertension,\n* allergy to sulphadoxine-pyrimethamine or azithromycin'}, 'identificationModule': {'nctId': 'NCT02527005', 'briefTitle': 'A Comparative Study of Azithromycin and S-P as Prophylaxis in Pregnant HIV+ Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Ibadan'}, 'officialTitle': 'A Comparative Study of Azithromycin and Sulphadoxine-pyrimethamine as Prophylaxis Against Malaria in Pregnant HIV Positive Patients', 'orgStudyIdInfo': {'id': 'UIbadan'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Azithromycin', 'description': 'Tabs Azithromycin 500mg daily for 3 days', 'interventionNames': ['Drug: Sulphadoxine-pyrimethamine', 'Drug: Azithromycin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sulphadoxine-pyrimethamine', 'description': '500mg of sulphadoxine and 25mg of pyrimethamine 3 tablets every 4 weeks for 3 doses', 'interventionNames': ['Drug: Sulphadoxine-pyrimethamine', 'Drug: Azithromycin']}], 'interventions': [{'name': 'Sulphadoxine-pyrimethamine', 'type': 'DRUG', 'otherNames': ['Vitadar'], 'description': 'Sulphadoxine-Pyrimethamine 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets monthly for 3 doses', 'armGroupLabels': ['Azithromycin', 'Sulphadoxine-pyrimethamine']}, {'name': 'Azithromycin', 'type': 'DRUG', 'otherNames': ['Zithromax'], 'description': 'Tabs Azithromycin 500mg daily for 3 days', 'armGroupLabels': ['Azithromycin', 'Sulphadoxine-pyrimethamine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200001', 'city': 'Ibadan', 'state': 'Oyo State', 'country': 'Nigeria', 'facility': 'University College Hospital,', 'geoPoint': {'lat': 7.37756, 'lon': 3.90591}}], 'overallOfficials': [{'name': 'AYODELE O AROWOJOLU, MBBS IBADAN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UNIVERSITY COLLEGE HOSPITAL,IBADAN,OYO STATE, NIGERIA'}, {'name': 'ORIYOMI O AKINYOTU, MBBS IBADAN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNIVERSITY COLLEGE HOSPITAL, IBADAN, OYO STATE, NIGERIA'}, {'name': 'ADENIKE F BELLO, MBBS IBADAN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UNIVERSITY COLLEGE HOSPITAL, IBADAN, OYO STATE, NIGERIA'}, {'name': 'ADEOLA R ABDUS-SALAM, MBBS IBADAN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ADEOYO MATERNITY TEACHING HOSPITAL, IBADAN, OYO STATE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ibadan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Registrar', 'investigatorFullName': 'ORIYOMI OMOTOYOSI AKINYOTU', 'investigatorAffiliation': 'University of Ibadan'}}}}