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

Primary Purpose

Malaria in Pregnant HIV + Patients

Status
Completed
Phase
Phase 1
Locations
Nigeria
Study Type
Interventional
Intervention
Mefloquine
Sulphadoxine-Pyrimethamine
Sponsored by
ORIYOMI OMOTOYOSI AKINYOTU
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria in Pregnant HIV + Patients focused on measuring Intermittent preventive therapy, malaria, pregnant, HIV positive, Prevention

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Mefloquine

Sulphadoxine-Pyrimethamine

Arm Description

Tabs Mefloquine 250mg 3 doses 4 weeks apart

500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets 4 weeks apart for 3 doses

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
August 5, 2015
Last Updated
December 7, 2017
Sponsor
ORIYOMI OMOTOYOSI AKINYOTU
Collaborators
University of Ibadan
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1. Study Identification

Unique Protocol Identification Number
NCT02524444
Brief Title
A Comparative Study of Mefloquine and S-P as Prophylaxis Against Malaria in Pregnant HIV + Patients
Official Title
A Comparative Study of Mefloquine and Sulphadoxine-pyrimethamine as Prophylaxis Against Malaria in Pregnant Human Immunodeficiency Virus Positive Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
ORIYOMI OMOTOYOSI AKINYOTU
Collaborators
University of Ibadan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Randomized controlled single blind prospective comparative study.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria in Pregnant HIV + Patients
Keywords
Intermittent preventive therapy, malaria, pregnant, HIV positive, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mefloquine
Arm Type
Active Comparator
Arm Description
Tabs Mefloquine 250mg 3 doses 4 weeks apart
Arm Title
Sulphadoxine-Pyrimethamine
Arm Type
Active Comparator
Arm Description
500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets 4 weeks apart for 3 doses
Intervention Type
Drug
Intervention Name(s)
Mefloquine
Other Intervention Name(s)
Larimef
Intervention Description
Tabs Mefloquine 250mg
Intervention Type
Drug
Intervention Name(s)
Sulphadoxine-Pyrimethamine
Other Intervention Name(s)
Vitadar, Fansidar
Intervention Description
Sulphadoxine 500mg , Pyrimethamine 25mg
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AYODELE O AROWOJOLU, MBBS IBADAN
Organizational Affiliation
UNIVERSITY COLLEGE HOSPITAL,IBADAN,OYO STATE, NIGERIA
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
ORIYOMI O AKINYOTU, MBBS IBADAN
Organizational Affiliation
UNIVERSITY COLLEGE HOSPITAL,IBADAN,OYO STATE,NIGERIA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ADENIKE F BELLO, MBBS IBADAN
Organizational Affiliation
UNIVERSITY COLLEGE HOSPITAL,IBADAN,OYO STATE, NIGERIA
Official's Role
Study Director
Facility Information:
Facility Name
University College Hospital
City
Ibadan
State/Province
OYO State
ZIP/Postal Code
200001
Country
Nigeria

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
8702037
Citation
Steketee RW, Wirima JJ, Slutsker L, Khoromana CO, Heymann DL, Breman JG. Malaria treatment and prevention in pregnancy: indications for use and adverse events associated with use of chloroquine or mefloquine. Am J Trop Med Hyg. 1996;55(1 Suppl):50-6. doi: 10.4269/ajtmh.1996.55.50.
Results Reference
background
PubMed Identifier
29719927
Citation
Akinyotu O, Bello F, Abdus-Salam R, Arowojolu A. Comparative study of mefloquine and sulphadoxine-pyrimethamine for malaria prevention among pregnant women with HIV in southwest Nigeria. Int J Gynaecol Obstet. 2018 Aug;142(2):194-200. doi: 10.1002/ijgo.12516. Epub 2018 May 25.
Results Reference
derived

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

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