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A Comparative Study of Mefloquine and S-P as Prophylaxis Against Malaria 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: NCT02524444
Recruitment Status : Completed
First Posted : August 14, 2015
Last Update Posted : December 11, 2017
Sponsor:
Collaborator:
University of Ibadan
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 in Pregnant HIV + Patients Drug: Mefloquine Drug: Sulphadoxine-Pyrimethamine 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 with Mefloquine as-intermittent preventive therapy in HIV-infected pregnant women.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
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
Study Start Date : September 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Malaria

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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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 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

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): NCT02524444


Locations
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Nigeria
University College Hospital
Ibadan, OYO State, Nigeria, 200001
Sponsors and Collaborators
ORIYOMI OMOTOYOSI AKINYOTU
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
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: ORIYOMI OMOTOYOSI AKINYOTU, SENIOR REGISTRAR, University of Ibadan
ClinicalTrials.gov Identifier: NCT02524444    
Other Study ID Numbers: FDAAA
First Posted: August 14, 2015    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by ORIYOMI OMOTOYOSI AKINYOTU, University of Ibadan:
Intermittent preventive therapy
malaria
pregnant
HIV positive
Prevention
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Pyrimethamine
Sulfadoxine
Fanasil, pyrimethamine drug combination
Mefloquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents