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Clinical Trials

MainTitle

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

The recruitment status of this study is unknown.

Verified August 2015

Sponsor
University of Ibadan


Information provided by (Responsible Party)
ORIYOMI OMOTOYOSI AKINYOTU, University of Ibadan

ClinicalTrials.gov Identifier
NCT02527005

First received: August 14, 2015
Last updated: August 17, 2015
Last Verified: August 2015
History of Changes
Purpose

Purpose

Randomized controlled single blind prospective comparative study

Condition Intervention Phase
Malaria
Pregnant
HIV

Drug : Sulphadoxine-pyrimethamine
Drug : Azithromycin
Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by ORIYOMI OMOTOYOSI AKINYOTU, University of Ibadan:

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 [ Time Frame: 6 months ]

Estimated Enrollment: 140
Study Start Date: September 2015
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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

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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 45 Years  
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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02527005

Contacts

Contact:   ORIYOMI O AKINYOTU, MBBS IBADAN +2348035044590 oriyomiddoc@yahoo.com
Contact:   ADENIKE F BELLO, MBBS IBADAN +2348037084505 nikeoluyemi@yahoo.com

Locations

Nigeria
University College Hospital, Not yet recruiting
Ibadan, Oyo, Nigeria, 200001
Contact: ORIYOMI O AKINYOTU, MBBS IBADAN    +2348035044590    oriyomiddoc@yahoo.com
Contact: ADENIKE F BELLO, MBBS IBADAN    +2348037084505    nikeoluyemi@yahoo.com

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
More Information

More Information


Responsible Party: ORIYOMI OMOTOYOSI AKINYOTU, Senior Registrar, University of Ibadan  
ClinicalTrials.gov Identifier: NCT02527005   History of Changes  
Other Study ID Numbers: UIbadan  
Study First Received: August 14, 2015  
Last Updated: August 17, 2015  

Keywords provided by ORIYOMI OMOTOYOSI AKINYOTU, University of Ibadan:

IPT
malaria
pregnant
HIV positive

Additional relevant MeSH terms:
Malaria
Pyrimethamine
Sulfadoxine
Fanasil, pyrimethamine drug combination

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.