HIV Diagnosis and Treatment at Birth for HIV Exposed Newborn Whose Mother Was Not Treated With Antiretroviral Therapy (ART) During Last Month Before Delivery : Strategy Evaluation in Guinea.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Proportion of newborns who have received an HIV diagnosis and reinforced preventive antiretroviral treatment at birth.
研究概览
简要总结
Principal objective Assess the operational efficacy of a strategy combining early diagnosis and preventive antiretroviral treatment systematically reinforced from the birth* among infants at high risk of infection with HIV** .
-
in a maximum of 48 hours after delivery
-
born from HIV infected mothers who received less than 4 weeks of antiretroviral therapy prior delivery and / or HIV infection diagnosed at delivery
Intervention, a combined strategy :
After positive HIV infection screening from mother in the delivery room and put on antiretroviral treatment of mothers with post partum according to national guidelines , newborns benefit :
- Early detection of HIV infection at birth
- Without awaiting the outcome of early detection result, a preventive reinforced antiretroviral treatment (zidovudine, lamivudine, nevirapine or zidovudine, lamivudine if their mother is infected with HIV-2), from birth for 12 weeks.
- Regular HIV screening until the end of breastfeeding or later to 18 months.
- In case of positive results of an HIV test, an antiretroviral treatment with zidovudine, lamivudine, lopinavir, ritonavir whatever serology HIV 1 or 2.
详细描述
Objectives Principal objective Assess the operational efficacy of a strategy combining early diagnosis and preventive antiretroviral treatment systematically reinforced from the birth* among infants at high risk of infection with HIV** .
* in a maximum of 48 hours after delivery
**born from HIV infected mothers who received less than 4 weeks of antiretroviral therapy prior delivery and / or HIV infection diagnosed at delivery Secondary objectives
- Measure the cascade management of HIV infected mothers and HIV infected infants
- Measure the tolerance of reinforced preventive antiretroviral treatment
- Describe the rate of mother to child transmission of HIV and its risk factors
- Describe the clinical and immuno-virologic outcomes in mothers, in HIV infected children and in HIV-non-infected children
- Evaluate the acceptability of the strategy by mothers and caregivers.
- Compare the early diagnosis of HIV infection with Abbott and Biocentric HIV RNA tests
Methodology Prospective non-comparative study of mother-child pairs whose mother is HIV-infected and received less than 4 weeks of antiretroviral therapy before birth or whose HIV infection has been diagnosed at birth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mother-child pairs whose mother is HIV-infected and received less than 4 weeks of antiretroviral therapy before delivery or whose HIV infection has been diagnosed at delivery
- •Mother who signed the informed consent form to participate in the study.
排除标准
- •Mother treated with antiretrovirals during the month preceding delivery
- •No inclusion for precautionary reason : clinical symptoms suggesting an opportunistic infection of the central nervous system.
- •No inclusion for monitoring difficulties
- •History or presence of allergy to the study drugs or their components
- •Symptoms, physical signs or laboratory values suggestive of systemic disorders, (including renal, hepatic, cardiovascular, pulmonary, skin, or psychiatric and other conditions, which could interfere with the interpretation of the trial results
研究组 & 干预措施
Reinforced preventive ARV therapy
The proposed reinforced preventive ARV Therapy will be administrated to all newborns exposed to HIV (zidovudine+lamivudine+nevirapine if the newborn is exposed to HIV-1 or HIV-1/2, zidovudine+lamivudine if the newborns exposed to HIV-2)
干预措施: Reinforced preventive ARV therapy (Drug)
结局指标
主要结局
Proportion of newborns who have received an HIV diagnosis and reinforced preventive antiretroviral treatment at birth.
时间窗: Day 2
Proportion of newborns who have received both HIV test and reinforced preventive antiretroviral treatment in a maximum of 48 hours after birth.
次要结局
- Proportion of mothers diagnosed with HIV who will initiate an antiretroviral therapy(Week 72)
- Proportion of children diagnosed with HIV who will initiate an antiretroviral therapy(Week 72)
- Proportion of mother-child pairs retained in the study with child having 2 PCR performed after stopping reinforced preventive antiretroviral treatment(Week 24)
- Proportion of mother-child pairs retained in the study(Week 72)