- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02527005
A Comparative Study of Azithromycin and S-P as Prophylaxis in Pregnant HIV+ Patients
December 7, 2017 updated by: ORIYOMI OMOTOYOSI AKINYOTU, University of Ibadan
A Comparative Study of Azithromycin and Sulphadoxine-pyrimethamine as Prophylaxis Against Malaria in Pregnant HIV Positive Patients
Randomized controlled single blind prospective comparative study
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
140
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oyo
-
Ibadan, Oyo, Nigeria, 200001
- University College Hospital,
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Azithromycin
Tabs Azithromycin 500mg daily for 3 days
|
Sulphadoxine-Pyrimethamine 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets monthly for 3 doses
Other Names:
Tabs Azithromycin 500mg daily for 3 days
Other Names:
|
Active Comparator: Sulphadoxine-pyrimethamine
500mg of sulphadoxine and 25mg of pyrimethamine 3 tablets every 4 weeks for 3 doses
|
Sulphadoxine-Pyrimethamine 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets monthly for 3 doses
Other Names:
Tabs Azithromycin 500mg daily for 3 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
August 14, 2015
First Submitted That Met QC Criteria
August 17, 2015
First Posted (Estimate)
August 18, 2015
Study Record Updates
Last Update Posted (Actual)
December 11, 2017
Last Update Submitted That Met QC Criteria
December 7, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Malaria
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Folic Acid Antagonists
- Anti-Infective Agents, Urinary
- Renal Agents
- Pyrimethamine
- Azithromycin
- Sulfadoxine
- Fanasil, pyrimethamine drug combination
Other Study ID Numbers
- UIbadan
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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