Clinical trial NCT02712801: Antiretroviral Regime for Viral Eradication in Newborns
Official title: Antiretroviral Regime for Viral Eradication in Newborns After Intervention Failure of Mother-to-child Transmission of HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV/AIDS and Infections
Keywords: HIV
antiretroviral treatment
child
testing
Lead sponsor: National Center for Women and Children's Health, China CDC
Sponsor class: OTHER_GOV
Collaborators: name: National Center for AIDS/STD Control and Prevention, China CDC
name: Maternal and Child Health Hospital of Yunan Province
name: Maternal and Child Health Hospital of Sichuan Province
name: Maternal and Child Health Hospital of Guangxi Province
name: Maternal and Child Health Hospital of Xinjiang Uygur Autonomous Region
name: Guangdong Provincial Maternal and Child Health Hospital
First posted: 2016-03-18
Enrollment: 600
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* children whose mother with HIV infection
* children whose mother received antiretroviral drugs after 36 gestational weeks or received no drugs before delivery
* live birth

Exclusion Criteria:

* birth weight is less than 2000g
* Apgar score is less than 3 at 1 minute after birth or less than 6 at 5 minute after birth .

Primary outcomes:
measure: HIV infection in children
timeFrame: 0-18 months old
measure: Functional HIV cure in children
timeFrame: 0-36 months old
Secondary outcomes:
measure: Mortality
timeFrame: 0-36 months old
measure: ART regime for HIV exposed children at high risk of infection
timeFrame: 0-36 months old
measure: Testing algorithm for early infant diagnosis of HIV
timeFrame: 0-4 weeks old
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Maternal and Child Health Hospital of Guangdong Province
state: Guangdong
city: Nanning
country: China
facility: Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Chengdu
country: China
facility: Maternal and Child Health Hospital of Sichuan Province
state: Sichuan
city: Urumqi
country: China
facility: Maternal and Child Health Hospital of Xinjiang Uygur Autonomous Region
state: Xinjiang
city: Kunming
country: China
facility: Maternal and Child Health Hospital of Yunan Province
state: Yunnan
Study officials:
affiliation: National Center for Women and Children's Health, China CDC
name: Xi Jin, M.D.
role: PRINCIPAL_INVESTIGATOR
References: