Elimination of Paediatric HIV-1 Infection: Evaluation of the Prevention Programme and Rescue Intervention Based on the Expanded Programme on Immunization (EPI). ANRS 12388 PREVENIR-PEV Study.
试验速览
- 阶段
- 2 期
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Prevention of HIV-1 transmission from HIV-1-positive mothers to their breastfeeding children
研究概览
简要总结
The second visit of the Expanded Programme of Immunization when the child is 2 months old (EPI-2) represents a unique opportunity to link the EPI and PMTCT programmes and to introduce preventive and therapeutic rescue interventions in order to 1) Assess the efficacy of the PMTCT cascade up to 2 months postpartum; 2) Allow at least 80% of HIV-1-infected infants identified at the second EPI visit who were not involved in HIV care to initiate ARVs at the earliest, but no later than 2 months after confirmation of HIV diagnosis; 3) Reduce HIV-1 transmission to less than 3% between 2 and 12 months among exposed children who completed the second EPI visit
详细描述
The WHO recommendation of lifelong antiretroviral therapy (ART) for all HIV-infected pregnant or breastfeeding women represents a major advance for universal access to HIV care but this strategy alone may not be sufficient to eliminate pediatric HIV in the communities.
Presently, the impact of prevention of mother-to-child HIV transmission (PMTCT) programs in the communities is unclear. There is also no available rescue intervention able to identify postpartum women at high risk of transmission in order to offer them adequate HIV care and prevent HIV acquisition by their breastfed infants.
We hypothesize that the second visit for routine vaccination (Expanded Program of Immunization visit 2, EPI-2) represents a unique opportunity to link EPI and PMTCT programs and introduce rescue preventive and therapeutic interventions.
The study will assess the efficacy of the PMTCT cascade up to 2 months post-partum for all mothers attending the EPI-2 (Component 1). For Component 1, the target population will be all 32,100 women participating in EPI-2 and verbally consenting to participate to evaluate the PMTCT program up to 2 months postpartum.
The consent form for component 2 will be proposed to all HIV positive mothers of component 1 who meet the inclusion and non-inclusion criteria. HIV-1 viral load measurement of the mothers and the detection of HIV-1 DNA in their children will be assessed. Children infected with HIV-1 will be referred for immediate ART initiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A mother-child couple will be included in the Phase IIb trial if the child:
- •is a singleton
- •is breastfed at about 2 months and the mother intends to continue breastfeeding for at least 4 months (until her child is 6 months old)
- •has a POC HIV-1 PCR negative test at about 2 months of age
- •has a mother who:
- •accompanies him to visit 2 of the EPI
- •is over 20 years of age or over or is a minor from the age of 15 and is accompanied by a referent adult of his/her choice representing his/her interests (parent, family member or guardian, member of an association, etc.)
- •has been confirmed to be infected with HIV-1 (with or without HIV-2)
- •signature of the consent to participate
- •for the mother signed by herself and a witness (if illiterate) and/or a referent adult (if under 20 years of age)
- •for the child: consent must be signed by both parents unless the mother exercises parental authority alone or if obtaining the father's consent is likely to endanger the mother and her child.
排除标准
- •A mother-child couple will not be included in the Phase IIb trial if the child:
- •exhibits DAIDS grade 3 or 4 clinical symptoms or biological anomalies for adverse events on the day of inclusion
- •has a severe congenital malformation
- •has a known allergy to the study drug or its components
- •is taking emtricitabine concomitantly
- •has a mother:
- •living outside the study area or planning to move from the area within the next 12 months
- •participating in another clinical trial on the day of inclusion
研究组 & 干预措施
Intervention
Lamivudine Oral Solution
干预措施: Lamivudine Oral Solution (Drug)
结局指标
主要结局
Prevention of HIV-1 transmission from HIV-1-positive mothers to their breastfeeding children
时间窗: 12 months
Postnatal HIV-1 transmission rates at 12 months in infants exposed to HIV-1 through breastfeeding.
次要结局
- Efficacy of PMTCT cascade - mother(2 months)
- Access to ART for HIV-1-positive children(6 months)
- Efficacy of PMTCT cascade - child(2 months)
- Number of Adverse Events Grade 3 and 4 in the prevention of HIV-1 via breastfeeding [Safety of lamivudine](12 months)