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Breastfeeding, Antiretroviral, and Nutrition Study

2010年4月22日 更新者：Centers for Disease Control and Prevention

HIV Infection and Breastfeeding: Interventions for Maternal and Infant Health

This is a comparative clinical trial among HIV-infected women and their infants to determine:

  1. the benefit of nutritional supplementation given to women during breastfeeding
  2. the benefit and safety of antiretroviral (ARV) medications given either to infants or to their mothers to prevent HIV transmission during breastfeeding
  3. the feasibility of exclusive breastfeeding followed by early, rapid breastfeeding cessation

研究概览

地位

完全的

条件

干预/治疗

详细说明

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:

  1. 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).
  2. 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.
  3. 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.

研究类型

介入性

注册 (实际的)

2369

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 马拉维
      • Lilongwe、马拉维
        • Kamuzu Central Hospital, Bottom Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

14年 及以上 (孩子、成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：阶乘赋值
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Maternal ARVs & Nutrition Supplement
Extended maternal ARVs for prophylaxis (for the infant) & daily nutritional supplement given to the mother
药品：Maternal zidovudine/lamivudine/lopinavir-ritonavir
Total daily dose: zidovudine 600mg, lamivudine 300mg, (taken as Combivir 1 tab twice a day with food). Lopinavir/ritonavir 400/100mg (taken as 2 tabs twice a day). Commencing after delivery and through to 28 weeks.
其他名称：
  • Combivir tabs (zidovudine 300mg and lamivudine 150mg)
  • Aluvia tabs (lopinavir 200mg /ritonavir 50mg)
膳食补充剂：Maternal protein and calorie supplement
High energy, nutrient-dense, micronutrient fortified nutritional supplement. Daily: Energy 700kcal, Protein 20g, 100% of recommended dietary allowance for all micronutrients during the 6 months of lactation. Vitamin A is excluded.
其他名称：
  • Produced by Nutriset. Daily dose: 2 sachets.
有源比较器：Infant NVP & Nutrition Supplement
Extended infant nevirapine for prophylaxis & daily nutritional supplment given to the mother
膳食补充剂：Maternal protein and calorie supplement
High energy, nutrient-dense, micronutrient fortified nutritional supplement. Daily: Energy 700kcal, Protein 20g, 100% of recommended dietary allowance for all micronutrients during the 6 months of lactation. Vitamin A is excluded.
其他名称：
  • Produced by Nutriset. Daily dose: 2 sachets.
药品：Infant nevirapine

Nevirapine suspension once daily dose. 0-14days: 10mg; 3-18weeks: 20mg; 19-28weeks: 30mg.

To 28 weeks while breastfeeding.

其他名称：
  • Viramune (Nevirapine) suspension 50mg/5ml
有源比较器：Maternal ARVs & No Nutrition Supplement
Extended maternal ARVs for prophylaxis (for the infant) & no nutritional supplement given to the mother
药品：Maternal zidovudine/lamivudine/lopinavir-ritonavir
Total daily dose: zidovudine 600mg, lamivudine 300mg, (taken as Combivir 1 tab twice a day with food). Lopinavir/ritonavir 400/100mg (taken as 2 tabs twice a day). Commencing after delivery and through to 28 weeks.
其他名称：
  • Combivir tabs (zidovudine 300mg and lamivudine 150mg)
  • Aluvia tabs (lopinavir 200mg /ritonavir 50mg)
有源比较器：Infant NVP & No Nutrition Supplement
Extended infant nevirapine for prophylaxis & no nutritional supplment given to the mother
药品：Infant nevirapine

Nevirapine suspension once daily dose. 0-14days: 10mg; 3-18weeks: 20mg; 19-28weeks: 30mg.

To 28 weeks while breastfeeding.

其他名称：
  • Viramune (Nevirapine) suspension 50mg/5ml
有源比较器：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.
膳食补充剂：Maternal protein and calorie supplement
High energy, nutrient-dense, micronutrient fortified nutritional supplement. Daily: Energy 700kcal, Protein 20g, 100% of recommended dietary allowance for all micronutrients during the 6 months of lactation. Vitamin A is excluded.
其他名称：
  • Produced by Nutriset. Daily dose: 2 sachets.
无干预：No Drugs & No Nutrition Supplement

No extended maternal ARV prophylaxis nor infant nevirapine prophylaxis & no 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.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Postpartum weight loss between delivery and 28 weeks
大体时间：between delivery and 28 weeks
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.)
大体时间：birth to 28 weeks
birth to 28 weeks
Exclusive breastfeeding and breastfeeding cessation by 28 weeks
大体时间：birth to 28 weeks
birth to 28 weeks

次要结果测量

结果测量
大体时间
Duration of exclusive breastfeeding
大体时间：birth to 28 weeks
birth to 28 weeks
Infant HIV status through 48 weeks
大体时间：birth to 48 weeks
birth to 48 weeks
Maternal adherence to ARV, maternal CD4 count, and clinical assessment of opportunistic infection status through 48 weeks
大体时间：delivery to 48 weeks
delivery to 48 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Centers for Disease Control and Prevention

合作者

University of North Carolina, Chapel Hill
Kamuzu Central Hospital

调查人员

  • 首席研究员：Peter Kazembe, MB ChB、Kamuzu Central Hospital
  • 学习椅：Charles van der Horst, MD、University of North Carolina, Chapel Hill
  • 首席研究员：Denise J Jamieson, MD, MPH、CDC, Atlanta, GA

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2004年3月1日

初级完成 (实际的)

2010年1月1日

研究完成 (实际的)

2010年1月1日

研究注册日期

首次提交

2005年9月13日

首先提交符合 QC 标准的

2005年9月13日

首次发布 (估计)

2005年9月14日

研究记录更新

最后更新发布 (估计)

2010年4月23日

上次提交的符合 QC 标准的更新

2010年4月22日

最后验证

2010年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CDC-NCCDPHP-3946
  • U48CCU409660 (其他赠款/资助编号：U.S. Centers for Disease Control and Prevention)
  • PA 04003 SIP 26-04 (其他赠款/资助编号：U.S. Centers for Disease Control and Prevention)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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