A Comparative Study of Azithromycin and S-P as Prophylaxis in Pregnant HIV+ Patients
NCT ID: NCT02527005
Last Updated: 2017-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
140 participants
INTERVENTIONAL
2015-09-30
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Azithromycin
Tabs Azithromycin 500mg daily for 3 days
Sulphadoxine-pyrimethamine
Sulphadoxine-Pyrimethamine 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets monthly for 3 doses
Azithromycin
Tabs Azithromycin 500mg daily for 3 days
Sulphadoxine-pyrimethamine
500mg of sulphadoxine and 25mg of pyrimethamine 3 tablets every 4 weeks for 3 doses
Sulphadoxine-pyrimethamine
Sulphadoxine-Pyrimethamine 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets monthly for 3 doses
Azithromycin
Tabs Azithromycin 500mg daily for 3 days
Interventions
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Sulphadoxine-pyrimethamine
Sulphadoxine-Pyrimethamine 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets monthly for 3 doses
Azithromycin
Tabs Azithromycin 500mg daily for 3 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Gestational age 16 weeks and above,
* No history of azithromycin or sulphadoxine-pyrimethamine use four weeks prior to recruitment
Exclusion Criteria
* pre-existing medical conditions- diabetes mellitus,
* hypertension,
* allergy to sulphadoxine-pyrimethamine or azithromycin
18 Years
45 Years
FEMALE
Yes
Sponsors
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University of Ibadan
OTHER
Responsible Party
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ORIYOMI OMOTOYOSI AKINYOTU
Senior Registrar
Principal Investigators
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AYODELE O AROWOJOLU, MBBS IBADAN
Role: STUDY_DIRECTOR
UNIVERSITY COLLEGE HOSPITAL,IBADAN,OYO STATE, NIGERIA
ORIYOMI O AKINYOTU, MBBS IBADAN
Role: PRINCIPAL_INVESTIGATOR
UNIVERSITY COLLEGE HOSPITAL, IBADAN, OYO STATE, NIGERIA
ADENIKE F BELLO, MBBS IBADAN
Role: STUDY_DIRECTOR
UNIVERSITY COLLEGE HOSPITAL, IBADAN, OYO STATE, NIGERIA
ADEOLA R ABDUS-SALAM, MBBS IBADAN
Role: STUDY_DIRECTOR
ADEOYO MATERNITY TEACHING HOSPITAL, IBADAN, OYO STATE
Locations
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University College Hospital,
Ibadan, Oyo State, Nigeria
Countries
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References
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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.
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.
Other Identifiers
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UIbadan
Identifier Type: -
Identifier Source: org_study_id
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