Back to resultsA Comparative Study of Azithromycin and S-P as Prophylaxis in Pregnant HIV+ Patients
Primary Purpose
Malaria, Pregnant, HIV
Status
Completed
Phase
Phase 1
Locations
Nigeria
Study Type
Interventional
Intervention
Sulphadoxine-pyrimethamine
Azithromycin
Sponsored by
About this trial
This is an interventional prevention trial for Malaria focused on measuring IPT, malaria, pregnant, HIV positive
Eligibility Criteria
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
Sites / Locations
- University College Hospital,
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Azithromycin
Sulphadoxine-pyrimethamine
Arm Description
Tabs Azithromycin 500mg daily for 3 days
500mg of sulphadoxine and 25mg of pyrimethamine 3 tablets every 4 weeks for 3 doses
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02527005
Brief Title
A Comparative Study of Azithromycin and S-P as Prophylaxis in Pregnant HIV+ Patients
Official Title
A Comparative Study of Azithromycin and Sulphadoxine-pyrimethamine as Prophylaxis Against Malaria in Pregnant HIV Positive Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ibadan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Randomized controlled single blind prospective comparative study
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria, Pregnant, HIV
Keywords
IPT, malaria, pregnant, HIV positive
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Azithromycin
Arm Type
Active Comparator
Arm Description
Tabs Azithromycin 500mg daily for 3 days
Arm Title
Sulphadoxine-pyrimethamine
Arm Type
Active Comparator
Arm Description
500mg of sulphadoxine and 25mg of pyrimethamine 3 tablets every 4 weeks for 3 doses
Intervention Type
Drug
Intervention Name(s)
Sulphadoxine-pyrimethamine
Other Intervention Name(s)
Vitadar
Intervention Description
Sulphadoxine-Pyrimethamine 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets monthly for 3 doses
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Other Intervention Name(s)
Zithromax
Intervention Description
Tabs Azithromycin 500mg daily for 3 days
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AYODELE O AROWOJOLU, MBBS IBADAN
Organizational Affiliation
UNIVERSITY COLLEGE HOSPITAL,IBADAN,OYO STATE, NIGERIA
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
ORIYOMI O AKINYOTU, MBBS IBADAN
Organizational Affiliation
UNIVERSITY COLLEGE HOSPITAL, IBADAN, OYO STATE, NIGERIA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ADENIKE F BELLO, MBBS IBADAN
Organizational Affiliation
UNIVERSITY COLLEGE HOSPITAL, IBADAN, OYO STATE, NIGERIA
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
ADEOLA R ABDUS-SALAM, MBBS IBADAN
Organizational Affiliation
ADEOYO MATERNITY TEACHING HOSPITAL, IBADAN, OYO STATE
Official's Role
Study Director
Facility Information:
Facility Name
University College Hospital,
City
Ibadan
State/Province
Oyo
ZIP/Postal Code
200001
Country
Nigeria
12. IPD Sharing Statement
Citations:
PubMed Identifier
10028075
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.
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A Comparative Study of Azithromycin and S-P as Prophylaxis in Pregnant HIV+ Patients
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