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Completed

NCT Number: NCT02524444

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

Randomized controlled single blind prospective comparative study.

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Key information

Conditions

Malaria in Pregnant HIV + Patients Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections HIV Seropositivity Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Malaria Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Vector Borne Diseases Virus Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

University College Hospital

Ibadan, Oyo State, 200001, Nigeria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mefloquine

Drug

Tabs Mefloquine 250mg

Other names: Larimef

Sulphadoxine-pyrimethamine

Drug

Sulphadoxine 500mg , Pyrimethamine 25mg

Other names: Vitadar, Fansidar

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

ORIYOMI OMOTOYOSI AKINYOTU

Other

Collaborators

  • University of Ibadan

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 14, 2015
Registry last updated
Dec 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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