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Maternal/Infant Peripartum NVP, Versus Infant Only Peripartum NVP, or Maternal LPV/r in Addition to Standard ZDV Prophylaxis for the Prevention of Perinatal (PMTCT) HIV in Thailand (PHPT-5)

2016年1月26日 更新者：Marc Lallemant、Institut de Recherche pour le Developpement

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.

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.

研究概览

地位

终止

条件

干预/治疗

详细说明

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+++

Arm 3: LPV/r:

  • In women, LPV/r 400/100 mg bid from 28 weeks' gestation until delivery

    • women in Arm 1 will also receive 7-day ZDV 300mg bid plus 3TC 150mg bid from delivery. ++women in Arm 2 will also receive 7-day (ZDV+3TC) Placebo from delivery. +++If the new born weight less than 2500 g, nevirapine will be administered 2 mg./1 kg (As per Thai Guideline).

All infants will receive ZDV for at least one week. Follow-up of women and infants is carried out on an outpatient basis except for delivery and the first three days after delivery. Mothers and infants are followed-up for 24 months after delivery.

Note: The study was stopped and data unblinded upon DSMB recommendations in September 2010 because of changes in Thai PMTCT guidelines recommending use of HAART in all HIV infected pregnant women regardless of their CD4 count. At the time of unblinding 435 pregnant women had been enrolled and follow-up of these women and their children is continuing.

研究类型

介入性

注册 (实际的)

435

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

  • 泰国
      • Bangkok、泰国、10220
        • Health Promotion Hospital Regional Center I
      • Chiang Mai、泰国、50100
        • Health Promotion Center Region 10,
      • Chiang Mai、泰国、50110
        • Fang Hospital
      • Chiang Mai、泰国、50160
        • Chomthong hospital
      • Chonburi、泰国、20180
        • Somdej Pranangchao Sirikit Hospital
      • Khon Kaen、泰国、40000
        • Regional Health Promotion Centre 6,
      • Lamphun、泰国、51000
        • Lamphun Hospital
      • Phayao、泰国、56000
        • Phayao Provincial Hospital
      • Phuket、泰国、83000
        • Vachira Phuket Hospital
      • Samutprakarn、泰国、10280
        • Samutprakarn Hospital
    • Bangkok
      • Kannayao、Bangkok、泰国、10230
        • Nopparat Rajathanee Hospital
      • Saimai、Bangkok、泰国
        • Bhumibol Adulyadej Hospital
    • Chachoengsao
      • Muang、Chachoengsao、泰国、24000
        • Chachoengsao Hospital
    • Chantaburi
      • Muang、Chantaburi、泰国、22000
        • Prapokklao Hospital
    • Chiang Mai
      • Mae Rim、Chiang Mai、泰国、50180
        • Nakornping Hospital
      • Sanpatong、Chiang Mai、泰国
        • Sanpatong Hospital
    • Chiang Rai
      • Mae Chan、Chiang Rai、泰国
        • Mae Chan Hospital
      • Mae Sai、Chiang Rai、泰国
        • Mae Sai Hospital
      • Phan、Chiang Rai、泰国
        • Phan Hospital
    • Chiangrai
      • Chiang Saen、Chiangrai、泰国、57150
        • Chiang Saen Hospital
      • Muang、Chiangrai、泰国、57000
        • Chiangrai Prachanukroh Hospital
      • Wiangpapao、Chiangrai、泰国、57170
        • Wiangpapao Hospital
    • Chonburi
      • Banglamung、Chonburi、泰国、20150
        • Banglamung Hospital
      • Muang、Chonburi、泰国、20000
        • Chonburi Hospital
      • Panasnikom、Chonburi、泰国、20140
        • Panasnikom Hospital
      • Sri Racha、Chonburi、泰国、20230
        • Ao Udom Hospital
    • Kalasin
      • Muang、Kalasin、泰国、46000
        • Kalasin Hospital
    • Kanjanaburi
      • Munag、Kanjanaburi、泰国、71000
        • Phaholpolphayuhasena Hospital
    • Khon Kaen
      • Muang、Khon Kaen、泰国
        • Khon Kaen Hospital
    • Lampang
      • Muang, Lampang、Lampang、泰国、52000
        • Lampang Hospital
    • Mahasarakam
      • Muang、Mahasarakam、泰国、44000
        • Mahasarakam Hospital
    • Nakhon Si Thammarat
      • Muang、Nakhon Si Thammarat、泰国、80000
        • Maharaj Nakhon Si Thammarat Hospital
    • Nakhonpathom
      • Muang、Nakhonpathom、泰国
        • Nakhonpathom Hospital
    • Nong Kai
      • Muang、Nong Kai、泰国、43000
        • Nong Khai Hospital
    • Nonthaburi
      • Muang、Nonthaburi、泰国
        • Pranangklao Hospital
    • Pathumthani
      • Muang、Pathumthani、泰国、12000
        • Pathumthani Hospital
    • Phayao
      • Chiang Kham、Phayao、泰国、56110
        • Chiang Kham Hospital
    • Pitsanulok
      • Muang、Pitsanulok、泰国
        • Buddhachinaraj Hospital
    • Rayong
      • Muang、Rayong、泰国、21000
        • Rayong Hospital
    • Samutsakhon
      • Muang、Samutsakhon、泰国、74000
        • Samutsakhon Hospital
    • Songkhla
      • Muangsongkhla、Songkhla、泰国、90100
        • Songkhla Hospital
    • Songkla
      • Hat Yai、Songkla、泰国、90110
        • Hat Yai Hospital
    • Trat
      • Muang、Trat、泰国、23000
        • Trat 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

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

有资格学习的性别

全部

描述

Pre-Entry Criteria

  • Evidence of HIV infection (documented by two HIV antibody tests on two different dates)
  • Intend to be followed at a study site for the duration of the study
  • At least 18 years old
  • Written informed consent.

Inclusion Criteria:

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.

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：并行分配
  • 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：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
药品：Maternal and infant nevirapine
  • In women, one NVP 200 mg tablet at onset of labor;
  • In neonates, NVP oral suspension 6 mg in the delivery room immediately
药品：zidovudine
In addition, all women and infants in the 3 arms will receive standard ZDV prophylaxis, as per Thai and WHO guidelines.
实验性的：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
药品：zidovudine
In addition, all women and infants in the 3 arms will receive standard ZDV prophylaxis, as per Thai and WHO guidelines.
药品：Maternal placebo and infant nevirapine
  • 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

Comparison between Arms 1 and 2 is double-blinded.
实验性的：3

LPV/r:

  • In women, LPV/r 400/100 mg bid from 28 weeks' gestation until delivery
药品：zidovudine
In addition, all women and infants in the 3 arms will receive standard ZDV prophylaxis, as per Thai and WHO guidelines.
药品：Maternal lopinavir+ritonavir
- In women, LPV/r 400/100 mg bid from 28 weeks' gestation until delivery

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Definitive HIV infection in infants as assessed by positive HIV DNA PCR on two peripheral blood samples
大体时间：At birth, 7-10 days, 1, 2, 4 and 6 months of age
At birth, 7-10 days, 1, 2, 4 and 6 months of age

次要结果测量

结果测量
大体时间
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.
大体时间：From randomization during pregnancy until 24 months after delivery
From randomization during pregnancy until 24 months after delivery

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

Institut de Recherche pour le Developpement

合作者

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Harvard School of Public Health (HSPH)

调查人员

  • 首席研究员：Marc Lallemant, MD、Institut de Recherche pour le Developpment

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

有用的网址

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

2008年7月1日

初级完成 (实际的)

2010年11月1日

研究完成 (实际的)

2015年6月1日

研究注册日期

首次提交

2006年12月8日

首先提交符合 QC 标准的

2006年12月8日

首次发布 (估计)

2006年12月11日

研究记录更新

最后更新发布 (估计)

2016年1月28日

上次提交的符合 QC 标准的更新

2016年1月26日

最后验证

2016年1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

  • PHPT-5 First Phase
  • R01HD052461 (美国 NIH 拨款/合同)
  • R01HD056953 (美国 NIH 拨款/合同)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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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赞助者和合作者

医疗条件

药物干预

CROs by country

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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