A Comparative Study of Mefloquine and S-P as Prophylaxis Against Malaria in Pregnant HIV + Patients
Phase 1
Completed
- Conditions
- Malaria in Pregnant HIV + Patients
- Interventions
- Drug: Sulphadoxine-Pyrimethamine
- Registration Number
- NCT02524444
- Lead Sponsor
- ORIYOMI OMOTOYOSI AKINYOTU
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 142
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sulphadoxine-Pyrimethamine Sulphadoxine-Pyrimethamine 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets 4 weeks apart for 3 doses Mefloquine Mefloquine Tabs Mefloquine 250mg 3 doses 4 weeks apart
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University College Hospital
🇳🇬Ibadan, OYO State, Nigeria