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A Comparative Study of Azithromycin and S-P as Prophylaxis in Pregnant HIV+ Patients

Sponsor
University of Ibadan (Other)
Overall Status
Completed
CT.gov ID
NCT02527005
Collaborator
(none)
140
Enrollment
1
Location
2
Arms
11
Duration (Months)
12.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Randomized controlled single blind prospective comparative study

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Comparative Study of Azithromycin and Sulphadoxine-pyrimethamine as Prophylaxis Against Malaria in Pregnant HIV Positive Patients
Study Start Date :
Sep 1, 2015
Actual Primary Completion Date :
Aug 1, 2016
Actual Study Completion Date :
Aug 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Azithromycin

Tabs Azithromycin 500mg daily for 3 days

Drug: Sulphadoxine-pyrimethamine
Sulphadoxine-Pyrimethamine 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets monthly for 3 doses
Other Names:
  • Vitadar

    • Drug: Azithromycin
    Tabs Azithromycin 500mg daily for 3 days
    Other Names:
  • Zithromax

    		•
    Active Comparator: Sulphadoxine-pyrimethamine

    500mg of sulphadoxine and 25mg of pyrimethamine 3 tablets every 4 weeks for 3 doses

    Drug: Sulphadoxine-pyrimethamine
    Sulphadoxine-Pyrimethamine 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets monthly for 3 doses
    Other Names:
  • Vitadar

    • Drug: Azithromycin
    Tabs Azithromycin 500mg daily for 3 days
    Other Names:
  • Zithromax

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University College Hospital, Ibadan Oyo Nigeria 200001

    Sponsors and Collaborators

    • University of Ibadan

    Investigators

    • Study Director: AYODELE O AROWOJOLU, MBBS IBADAN, UNIVERSITY COLLEGE HOSPITAL,IBADAN,OYO STATE, NIGERIA
    • Principal Investigator: ORIYOMI O AKINYOTU, MBBS IBADAN, UNIVERSITY COLLEGE HOSPITAL, IBADAN, OYO STATE, NIGERIA
    • Study Director: ADENIKE F BELLO, MBBS IBADAN, UNIVERSITY COLLEGE HOSPITAL, IBADAN, OYO STATE, NIGERIA
    • Study Director: ADEOLA R ABDUS-SALAM, MBBS IBADAN, ADEOYO MATERNITY TEACHING HOSPITAL, IBADAN, OYO STATE

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    ORIYOMI OMOTOYOSI AKINYOTU, Senior Registrar, University of Ibadan
    ClinicalTrials.gov Identifier:
    NCT02527005
    Other Study ID Numbers:
    • UIbadan
    First Posted:
    Aug 18, 2015
    Last Update Posted:
    Dec 11, 2017
    Last Verified:
    Dec 1, 2017
    Keywords provided by ORIYOMI OMOTOYOSI AKINYOTU, Senior Registrar, University of Ibadan
    IPT
    malaria
    pregnant
    HIV positive
    Additional relevant MeSH terms:
    Malaria
    Azithromycin
    Pyrimethamine
    Sulfadoxine
    Fanasil, pyrimethamine drug combination

    Study Results

    No Results Posted as of Dec 11, 2017