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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02524444

Enrollment

142

Registered

2015-08-14

Start date

2015-09-30

Completion date

2016-08-31

Last updated

2017-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria in Pregnant HIV + Patients

Keywords

Intermittent preventive therapy, malaria, pregnant, HIV positive, Prevention

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.

Interventions

DRUGMefloquine

Tabs Mefloquine 250mg

DRUGSulphadoxine-Pyrimethamine

Sulphadoxine 500mg , Pyrimethamine 25mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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	6 months

Countries

Nigeria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026