This is a multi-center, randomized, controlled, open clinical trial. The trial will be carried out in five provinces in China. Pregnant women with HIV infection and at high risk of mother-to-child transmission of HIV will be identified. Their newborn babies who are at high risk HIV infection will be recruited and randomized into intervention and control groups. Children in intervention groups will receive ART and intensive HIV testing after birth. Children in control group will receive routine prevention of mother-to-child transmission services. All the included children will be followed up and their development and infection status will be recorded and compared.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
600
Dose will be adjusted according to the child's weight.
Dose will be adjusted according to the child's weight.
Dose will be adjusted according to the child's weight.
Dose will be adjusted according to the child's weight.
Maternal and Child Health Hospital of Guangdong Province
Guangzhou, Guangdong, China
Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Maternal and Child Health Hospital of Sichuan Province
Chengdu, Sichuan, China
Maternal and Child Health Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, China
Maternal and Child Health Hospital of Yunan Province
Kunming, Yunnan, China
HIV infection in children
Number of children diagnosed with HIV infection
Time frame: 0-18 months old
Functional HIV cure in children
Number of children with functional HIV cure
Time frame: 0-36 months old
Mortality
Number of children died
Time frame: 0-36 months old
ART regime for HIV exposed children at high risk of infection
ART regime to be used for functional HIV cure in children
Time frame: 0-36 months old
Testing algorithm for early infant diagnosis of HIV
Testing methods and algorithm for HIV exposed infants
Time frame: 0-4 weeks old
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