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

Malaria in Pregnant HIV + Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02524444
• Other study ID #: FDAAA
• Status: Completed
• Phase: Phase 1
• First received: August 5, 2015
• Last updated: December 7, 2017
• Start date: September 2015
• Est. completion date: August 2016

Study information

• Verified date: December 2017
• Source: University of Ibadan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized controlled single blind prospective comparative study.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Seropositivity
• Malaria
• Malaria in Pregnant HIV + Patients

Intervention

Drug:
• Mefloquine
Tabs Mefloquine 250mg
• Sulphadoxine-Pyrimethamine
Sulphadoxine 500mg , Pyrimethamine 25mg

Locations

Country	Name	City	State
Nigeria	University College Hospital	Ibadan	OYO State

Sponsors (2)

Lead Sponsor	Collaborator
ORIYOMI OMOTOYOSI AKINYOTU	University of Ibadan

Country where clinical trial is conducted

Nigeria, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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