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

NCT ID: NCT02524444

Last Updated: 2017-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-08-31

Brief Summary

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Randomized controlled single blind prospective comparative study.

Detailed Description

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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.

Conditions

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Malaria in Pregnant HIV + Patients

Keywords

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Intermittent preventive therapy malaria pregnant HIV positive Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mefloquine

Tabs Mefloquine 250mg 3 doses 4 weeks apart

Group Type ACTIVE_COMPARATOR

Mefloquine

Intervention Type DRUG

Tabs Mefloquine 250mg

Sulphadoxine-Pyrimethamine

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

Group Type ACTIVE_COMPARATOR

Sulphadoxine-Pyrimethamine

Intervention Type DRUG

Sulphadoxine 500mg , Pyrimethamine 25mg

Interventions

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Mefloquine

Tabs Mefloquine 250mg

Intervention Type DRUG

Sulphadoxine-Pyrimethamine

Sulphadoxine 500mg , Pyrimethamine 25mg

Intervention Type DRUG

Other Intervention Names

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Larimef Vitadar, Fansidar

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Ibadan

OTHER

Sponsor Role collaborator

ORIYOMI OMOTOYOSI AKINYOTU

OTHER

Sponsor Role lead

Responsible Party

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ORIYOMI OMOTOYOSI AKINYOTU

SENIOR REGISTRAR

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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AYODELE O AROWOJOLU, MBBS IBADAN

Role: STUDY_DIRECTOR

UNIVERSITY COLLEGE HOSPITAL,IBADAN,OYO STATE, NIGERIA

ORIYOMI O AKINYOTU, MBBS IBADAN

Role: PRINCIPAL_INVESTIGATOR

UNIVERSITY COLLEGE HOSPITAL,IBADAN,OYO STATE,NIGERIA

ADENIKE F BELLO, MBBS IBADAN

Role: STUDY_DIRECTOR

UNIVERSITY COLLEGE HOSPITAL,IBADAN,OYO STATE, NIGERIA

Locations

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University College Hospital

Ibadan, Oyo State, Nigeria

Site Status

Countries

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Nigeria

References

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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.

Reference Type BACKGROUND
PMID: 8702037 (View on PubMed)

Pons-Duran C, Wassenaar MJ, Yovo KE, Marin-Carballo C, Briand V, Gonzalez R. Intermittent preventive treatment regimens for malaria in HIV-positive pregnant women. Cochrane Database Syst Rev. 2024 Sep 26;9(9):CD006689. doi: 10.1002/14651858.CD006689.pub3.

Reference Type DERIVED
PMID: 39324693 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29719927 (View on PubMed)

Other Identifiers

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FDAAA

Identifier Type: -

Identifier Source: org_study_id