A Comparative Study of Mefloquine and Sulphadoxine-pyrimethamine as Prophylaxis Against Malaria in Pregnant Human Immunodeficiency Virus Positive Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Level of malaria parasitemia in HIV positive women at delivery after administration of Mefloquine or sulphadoxine-pyrimethamine as prophylaxis for malaria in pregnancy
研究概览
简要总结
Randomized controlled single blind prospective comparative study.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant HIV positive patients
- •Gestational age 16 weeks and above
- •No history of use of Mefloquine or Sulphadoxine
- •Pyrimethamine four weeks prior to recruitment.
排除标准
- •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
研究组 & 干预措施
Mefloquine
Tabs Mefloquine 250mg 3 doses 4 weeks apart
干预措施: Mefloquine (Drug)
Sulphadoxine-Pyrimethamine
500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets 4 weeks apart for 3 doses
干预措施: Sulphadoxine-Pyrimethamine (Drug)
结局指标
主要结局
Level of malaria parasitemia in HIV positive women at delivery after administration of Mefloquine or sulphadoxine-pyrimethamine as prophylaxis for malaria in pregnancy
时间窗: 6 months
次要结局
未报告次要终点
研究者
ORIYOMI OMOTOYOSI AKINYOTU
SENIOR REGISTRAR
University of Ibadan