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

December 7, 2017 updated by: ORIYOMI OMOTOYOSI AKINYOTU

A Comparative Study of Mefloquine and Sulphadoxine-pyrimethamine as Prophylaxis Against Malaria in Pregnant Human Immunodeficiency Virus Positive Patients

Randomized controlled single blind prospective comparative study.

Study Overview

Status

Completed

Conditions

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 with Mefloquine as-intermittent preventive therapy in HIV-infected pregnant women.

Study Type

Interventional

Enrollment (Actual)

142

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

  • Nigeria
    • OYO State
      • Ibadan, OYO State, 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

Yes

Genders Eligible for Study

Female

Description

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

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Mefloquine
Tabs Mefloquine 250mg 3 doses 4 weeks apart
Drug: Mefloquine
Tabs Mefloquine 250mg
Other Names:
  • 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 Names:
  • Vitadar, Fansidar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ORIYOMI OMOTOYOSI AKINYOTU

Collaborators

University of Ibadan

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

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.

General Publications

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 5, 2015

First Submitted That Met QC Criteria

August 12, 2015

First Posted (ESTIMATE)

August 14, 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

Other Study ID Numbers

  • FDAAA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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