NCT00409591终止3 期
Maternal and Infant Peripartum Nevirapine, Versus Infant Only Peripartum Nevirapine, or Maternal Lopinavir/Ritonavir in Addition to Standard Zidovudine Prophylaxis for the Prevention of Perinatal HIV in Thailand.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 435
- 试验地点
- 43
- 主要终点
- Definitive HIV infection in infants as assessed by positive HIV DNA PCR on two peripheral blood samples
研究概览
简要总结
The purpose of this study is to compare the efficacy of two doses of nevirapine (NVP) given only to the infants or lopinavir/ritonavir (LPV/r) from 28 weeks gestation with single dose (SD) NVP given to the mothers plus two doses to the infants, in addition to zidovudine (ZDV) prophylaxis (from 28 weeks' gestation and for one week of ZDV in neonates) for the prevention of mother-to-child transmission of HIV-1.
详细描述
Multicenter, placebo-controlled, double blind, clinical trial where non immunocompromised women receiving the ZDV prophylaxis regimen from 28 weeks gestation, as recommended in Thailand, will be randomized to one of two arms:
Arm 1: NVP-NVP:
- In women, one NVP 200 mg tablet at onset of labor+;
- In neonates, NVP oral suspension 6 mg in the delivery room immediately after birth plus a second dose between 48 and 72 hours+++
Arm 2: PL-NVP:
- In women, one placebo tablet at onset of labor++;
- In neonates, NVP oral suspension 6 mg in the delivery room immediately after birth plus a second dose between 48 and 72 hours+++
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women are eligible for the study if they
- •met all pre-entry criteria
- •Evidence of HIV infection, as documented by two serology tests obtained at two different dates;
- •between 28 and 36 weeks gestational age;
- •antiretroviral naïve except for exposure to ZDV prophylaxis PMTCT;
- •CD4 count above 250 cells/mm3 (within 4 months prior to randomization)
- •agreement not to breastfeed;
- •consent to participate and to be followed for the duration of the study;
- •and the following laboratory values within 14 days prior to randomization:
- •hemoglobin > 8.5 mg/dl;
- •absolute neutrophil count > 750 cells/mm3;
- •platelets > 50,000 cells/mm3;
- •SGPT ≤ 5 times upper limit of normal;
- •serum creatinine ≤ 1.5 times upper limit of normal (women with a serum creatinine > 1.5 times upper limit of normal must have a measured eight-hour urine creatinine clearance > 70 ml/min).
- •Exclusion criteria:
- •Evidence of pre-existing fetal anomalies incompatible with life;
- •patients who meet the criteria of Classes III/IV of the WHO classification of HIV-associated clinical disease;
- •known hypersensitivity to any benzodiazepine;
- •active tuberculosis;
- •concurrent participation to any other clinical trial;
- •receipt of benzodiazepines or antiretroviral agent other than ZDV;
- •uncontrolled hypertension;
- •anticoagulant therapy or magnesium sulfate within 2 weeks of enrollment or the need for them during labor or at delivery.
- •If any of these conditions occurs after randomization, the women will be excluded from study drug dosing. Women with CD4 count lower than 250 cells/mm3 will be excluded from the study and offered HAART in the context of the national program.
排除标准
- 未提供
研究组 & 干预措施
1
Active Comparator
NVP-NVP:
- In women, one NVP 200 mg tablet at onset of labor;
- In neonates, NVP oral suspension 6 mg in the delivery room immediately after birth plus a second dose between 48 and 72 hours
干预措施: Maternal and infant nevirapine (Drug)
1
Active Comparator
NVP-NVP:
- In women, one NVP 200 mg tablet at onset of labor;
- In neonates, NVP oral suspension 6 mg in the delivery room immediately after birth plus a second dose between 48 and 72 hours
干预措施: zidovudine (Drug)
2
Experimental
PL-NVP:
- In women, one placebo tablet at onset of labor;
- In neonates, NVP oral suspension 6 mg in the delivery room immediately after birth plus a second dose between 48 and 72 hours
干预措施: Maternal placebo and infant nevirapine (Drug)
2
Experimental
PL-NVP:
- In women, one placebo tablet at onset of labor;
- In neonates, NVP oral suspension 6 mg in the delivery room immediately after birth plus a second dose between 48 and 72 hours
干预措施: zidovudine (Drug)
3
Experimental
LPV/r:
- In women, LPV/r 400/100 mg bid from 28 weeks' gestation until delivery
干预措施: Maternal lopinavir+ritonavir (Drug)
3
Experimental
LPV/r:
- In women, LPV/r 400/100 mg bid from 28 weeks' gestation until delivery
干预措施: zidovudine (Drug)
结局指标
主要结局
Definitive HIV infection in infants as assessed by positive HIV DNA PCR on two peripheral blood samples
时间窗: At birth, 7-10 days, 1, 2, 4 and 6 months of age
次要结局
- Safety for mothers and children of two NVP doses in neonates with and without maternal single dose NVP at onset of labor or LPV/r from 28 weeks gestation.(From randomization during pregnancy until 24 months after delivery)
研究者
Marc Lallemant
Senior Researcher
Institut de Recherche pour le Developpement
研究点 (43)
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