HIV/AIDS and Infections
Conditions
Keywords
HIV, antiretroviral treatment, child, testing
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.
Interventions
DRUGZidovudine
Dose will be adjusted according to the child's weight.
DRUGNevirapine
Dose will be adjusted according to the child's weight.
DRUGLamivudine
Dose will be adjusted according to the child's weight.
DRUGLopinavir/ritonavir
Dose will be adjusted according to the child's weight.
Sponsors
National Center for AIDS/STD Control and Prevention, China CDC
Maternal and Child Health Hospital of Yunan Province
Maternal and Child Health Hospital of Sichuan Province
Maternal and Child Health Hospital of Guangxi Province
Maternal and Child Health Hospital of Xinjiang Uygur Autonomous Region
Guangdong Provincial Maternal and Child Health Hospital
National Center for Women and Children's Health, China CDC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Days to 1 Days
Healthy volunteers
No
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HIV infection in children | 0-18 months old | Number of children diagnosed with HIV infection |
| Functional HIV cure in children | 0-36 months old | Number of children with functional HIV cure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 0-36 months old | Number of children died |
| ART regime for HIV exposed children at high risk of infection | 0-36 months old | ART regime to be used for functional HIV cure in children |
| Testing algorithm for early infant diagnosis of HIV | 0-4 weeks old | Testing methods and algorithm for HIV exposed infants |
Countries
China
Outcome results
None listed