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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02527005 |
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Date of registration:
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14/08/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Comparative Study of Azithromycin and S-P as Prophylaxis in Pregnant HIV+ Patients
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Scientific title:
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A Comparative Study of Azithromycin and Sulphadoxine-pyrimethamine as Prophylaxis Against Malaria in Pregnant HIV Positive Patients |
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Date of first enrolment:
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September 2015 |
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Target sample size:
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140 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02527005 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
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Phase:
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Phase 1
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Countries of recruitment
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Nigeria
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Contacts
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Name:
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AYODELE O AROWOJOLU, MBBS IBADAN |
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Address:
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Telephone:
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Email:
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Affiliation:
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UNIVERSITY COLLEGE HOSPITAL,IBADAN,OYO STATE, NIGERIA |
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Name:
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ORIYOMI O AKINYOTU, MBBS IBADAN |
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Address:
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Telephone:
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Email:
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Affiliation:
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UNIVERSITY COLLEGE HOSPITAL, IBADAN, OYO STATE, NIGERIA |
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Name:
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ADEOLA R ABDUS-SALAM, MBBS IBADAN |
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Address:
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Telephone:
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Email:
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Affiliation:
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ADEOYO MATERNITY TEACHING HOSPITAL, IBADAN, OYO STATE |
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Name:
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ADENIKE F BELLO, MBBS IBADAN |
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Address:
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Telephone:
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Email:
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Affiliation:
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UNIVERSITY COLLEGE HOSPITAL, IBADAN, OYO STATE, NIGERIA |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Pregnant HIV positive patients,
- Gestational age 16 weeks and above,
- No history of azithromycin or sulphadoxine-pyrimethamine use four weeks prior to
recruitment
Exclusion Criteria:
- Anaemia packed cell volume less than 30%,
- pre-existing medical conditions- diabetes mellitus,
- hypertension,
- allergy to sulphadoxine-pyrimethamine or azithromycin
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Malaria
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HIV
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Pregnant
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Intervention(s)
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Drug: Azithromycin
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Drug: Sulphadoxine-pyrimethamine
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Primary Outcome(s)
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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
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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