HIV Infection and Breastfeeding: Interventions for Maternal and Infant Health
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,369
- 试验地点
- 1
- 主要终点
- Postpartum weight loss between delivery and 28 weeks
研究概览
简要总结
This is a comparative clinical trial among HIV-infected women and their infants to determine:
- the benefit of nutritional supplementation given to women during breastfeeding
- the benefit and safety of antiretroviral (ARV) medications given either to infants or to their mothers to prevent HIV transmission during breastfeeding
- the feasibility of exclusive breastfeeding followed by early, rapid breastfeeding cessation
详细描述
This study addresses the complex issues of HIV related maternal morbidity, mortality, and postnatal HIV transmission during breastfeeding and weaning in resource-poor countries. Objectives include assessment of mortality and morbidity among HIV-infected women; evaluation of interventions to reduce HIV transmission to infants exposed by breast milk; and assessment of early weaning as a risk-reduction strategy for infants of HIV-infected mothers.
The study will evaluate the following:
- The efficacy of a high-density caloric/micronutrient nutritional supplement given to HIV-infected women who breastfeed in preventing maternal depletion (weight loss and micronutrient status).
- The safety and efficacy of maternal or infant antiretroviral regimens, taken for up to 6 months during breastfeeding, in reducing infant HIV infection rates at 48 weeks.
- The feasibility of exclusive breastfeeding for 6 months followed by rapid weaning.
Additional study objectives are to evaluate the feasibility of delivering these interventions in resource poor settings and to identify maternal, infant, and virologic factors associated with HIV transmission during breastfeeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Recruitment and primary eligibility criteria:
- •Age > 14 years.
- •Ability to give informed assent or consent.
- •Evidence of HIV infection, as documented by 2 positive ELISA antibody tests; or 1 positive ELISA, and 1 Western Blot; or 2 separate concurrent rapid tests.
- •Currently pregnant (with a single or multiple fetuses).
- •Gestation < 30 weeks at referral from 'Call to Action' Program
- •No serious current complications of pregnancy.
- •Intention to breastfeed.
- •Intention to deliver at the institution at which the study is based.
- •Not previously enrolled in this study for an earlier pregnancy.
- •Other than HIV, no active serious infection, such as tuberculosis or other potentially serious illnesses.
- •No previous use of antiretrovirals including the HIVNET 012 regimen.
- •Mother's CD4 count > 250 cells/uL determined in the antenatal clinic.
- •Mother's ALT < 2.5 x ULN (upper limit of normal) determined in the antenatal clinic
- •Secondary eligibility criteria and treatment assignment:
- •Mother who delivers outside of the institution at which the study is based must present with her infant to the study site within 36 hours of delivery.
- •Mother accepts nevirapine and zidovudine+lamivudine 7-day regimen for herself and her infant.
- •Infant birth weight > 2000 g.
- •No severe congenital malformations or other condition(s) not compatible with life.
- •Based on clinical assessment, no maternal condition which would preclude the start of the study intervention.
排除标准
- 未提供
研究组 & 干预措施
Maternal ARVs & Nutrition Supplement
Extended maternal ARVs for prophylaxis (for the infant) & daily nutritional supplement given to the mother
干预措施: Maternal zidovudine/lamivudine/lopinavir-ritonavir (Drug)
Maternal ARVs & Nutrition Supplement
Extended maternal ARVs for prophylaxis (for the infant) & daily nutritional supplement given to the mother
干预措施: Maternal protein and calorie supplement (Dietary Supplement)
Infant NVP & Nutrition Supplement
Extended infant nevirapine for prophylaxis & daily nutritional supplment given to the mother
干预措施: Infant nevirapine (Drug)
Infant NVP & Nutrition Supplement
Extended infant nevirapine for prophylaxis & daily nutritional supplment given to the mother
干预措施: Maternal protein and calorie supplement (Dietary Supplement)
Maternal ARVs & No Nutrition Supplement
Extended maternal ARVs for prophylaxis (for the infant) & no nutritional supplement given to the mother
干预措施: Maternal zidovudine/lamivudine/lopinavir-ritonavir (Drug)
Infant NVP & No Nutrition Supplement
Extended infant nevirapine for prophylaxis & no nutritional supplment given to the mother
干预措施: Infant nevirapine (Drug)
No Drugs & Nutrition Supplement
No extended maternal ARV prophylaxis nor infant nevirapine prophylaxis & daily nutritional supplement given to the mother.
Note: As of March 2008, the third arm of the antiretroviral intervention, in which neither mother nor infant received drugs beyond enhanced standard of care, was stopped based on recommendations of a Data and Safety Monitoring Board review of interim efficacy results and safety data after 77% participants had received treatment assignment.
干预措施: Maternal protein and calorie supplement (Dietary Supplement)
结局指标
主要结局
Postpartum weight loss between delivery and 28 weeks
时间窗: between delivery and 28 weeks
Infant HIV status at 28 weeks. (Infants found to have HIV at birth or 2 weeks after delivery will have been disenrolled.)
时间窗: birth to 28 weeks
Exclusive breastfeeding and breastfeeding cessation by 28 weeks
时间窗: birth to 28 weeks
次要结局
- Duration of exclusive breastfeeding(birth to 28 weeks)
- Infant HIV status through 48 weeks(birth to 48 weeks)
- Maternal adherence to ARV, maternal CD4 count, and clinical assessment of opportunistic infection status through 48 weeks(delivery to 48 weeks)