Clinical Trials

MainTitle

A Comparative Study of Mefloquine and S-P as Prophylaxis Against Malaria in Pregnant HIV + Patients

The recruitment status of this study is unknown.

Verified August 2015 by ORIYOMI OMOTOYOSI AKINYOTU, University of Ibadan

Sponsor
ORIYOMI OMOTOYOSI AKINYOTU

Collaborator
University of Ibadan

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

ClinicalTrials.gov Identifier
NCT02524444

First received: August 5, 2015
Last updated: August 12, 2015
Last Verified: August 2015
History of Changes
Purpose

Purpose

Randomized controlled single blind prospective comparative study.

Condition Intervention Phase
Malaria in Pregnant HIV + Patients

Drug : Mefloquine
Drug : Sulphadoxine-Pyrimethamine
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 Mefloquine and Sulphadoxine-pyrimethamine as Prophylaxis Against Malaria in Pregnant Human Immunodeficiency Virus Positive Patients

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

Primary Outcome Measures

  • Level of malaria parasitemia in HIV positive women at delivery after administration of Mefloquine or sulphadoxine-pyrimethamine as prophylaxis 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: Mefloquine
Tabs Mefloquine 250mg 3 doses 4 weeks apart
Drug: Mefloquine

Tabs Mefloquine 250mg

Other Name: Larimef
Active Comparator: Sulphadoxine-Pyrimethamine
500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets 4 weeks apart for 3 doses
Drug: Sulphadoxine-Pyrimethamine

Sulphadoxine 500mg , Pyrimethamine 25mg

Other Name: Vitadar, Fansidar

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 with Mefloquine as-intermittent preventive therapy in HIV-infected 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 use of Mefloquine or Sulphadoxine
  • Pyrimethamine 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 Mefloquine
  • Non-consenting patients
  • Multiple gestation
  • Known psychiatric illness
  • Known seizure disorder
  • History of severe renal or hepatic disease

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: NCT02524444

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 State, Nigeria, 200001
Contact: ORIYOMI O AKINYOTU, MBBS IBADAN    +2348035044590    oriyomiddoc@yahoo.com
Contact: ADENIKE F BELLO, MBBS IBADAN    +2348037084505    nikeoluyemi@yahoo.com
Principal Investigator: ORIYOMI O AKINYOTU, MBBS IBADAN

Sponsors and Collaborators

ORIYOMI OMOTOYOSI AKINYOTU
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
More Information

More Information


Responsible Party: ORIYOMI OMOTOYOSI AKINYOTU, SENIOR REGISTRAR, University of Ibadan  
ClinicalTrials.gov Identifier: NCT02524444   History of Changes  
Other Study ID Numbers: FDAAA  
Study First Received: August 5, 2015  
Last Updated: August 12, 2015  

Keywords provided by ORIYOMI OMOTOYOSI AKINYOTU, University of Ibadan:

Intermittent preventive therapy
malaria
pregnant
HIV positive
Prevention

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

ClinicalTrials.gov processed this data on December 08, 2017
This information is provided by ClinicalTrials.gov.