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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02527005
Recruitment Status : Completed
First Posted : August 18, 2015
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
ORIYOMI OMOTOYOSI AKINYOTU, University of Ibadan

Brief Summary:
Randomized controlled single blind prospective comparative study

Condition or disease Intervention/treatment Phase
Malaria Pregnant HIV Drug: Sulphadoxine-pyrimethamine Drug: Azithromycin 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

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Study Type : Interventional  (Clinical Trial)
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 : September 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016


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 Name: Vitadar

Drug: Azithromycin
Tabs Azithromycin 500mg daily for 3 days
Other Name: 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 Name: Vitadar

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




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 [ Time Frame: 6 months ]


Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02527005


Locations
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Nigeria
University College Hospital,
Ibadan, Oyo, Nigeria, 200001
Sponsors and Collaborators
University of Ibadan
Investigators
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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
Publications:
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Responsible Party: ORIYOMI OMOTOYOSI AKINYOTU, Senior Registrar, University of Ibadan
ClinicalTrials.gov Identifier: NCT02527005    
Other Study ID Numbers: UIbadan
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: December 2017
Keywords provided by ORIYOMI OMOTOYOSI AKINYOTU, University of Ibadan:
IPT
malaria
pregnant
HIV positive
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Azithromycin
Pyrimethamine
Sulfadoxine
Fanasil, pyrimethamine drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents