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

ORIYOMI OMOTOYOSI AKINYOTU

Status and phase: Completed; Phase 1

Conditions: Malaria in Pregnant HIV + Patients

Treatments: Drug: Mefloquine; Drug: Sulphadoxine-Pyrimethamine

Study type: Interventional

Funder types: Other

Identifiers

NCT02524444

FDAAA

Details and patient eligibility

About

Randomized controlled single blind prospective comparative study.

Full 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.

Enrollment: 142 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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142 participants in 2 patient groups

Mefloquine

Active Comparator group

Description:

Tabs Mefloquine 250mg 3 doses 4 weeks apart

Treatment:

Drug: Mefloquine

Sulphadoxine-Pyrimethamine

Active Comparator group

Description:

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

Treatment:

Drug: Sulphadoxine-Pyrimethamine