Antiretroviral Regime for Viral Eradication in Newborns
- Conditions
- HIV/AIDS and Infections
- Interventions
- Registration Number
- NCT02712801
- Lead Sponsor
- National Center for Women and Children's Health, China CDC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
- children whose mother with HIV infection
- children whose mother received antiretroviral drugs after 36 gestational weeks or received no drugs before delivery
- live birth
- 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 .
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Lopinavir/ritonavir Children will receive antiretroviral treatment (ART) until 6 weeks old after birth. For the first two weeks, Zidovudine (AZT), Lamivudine (3TC) and Nevirapine (NVP) will be used. When the child is 2 weeks old, the regimen will be adjusted and Nevirapine (NVP) will be replaced by Lopinavir/ritonavir (LPV/r). Early infant diagnosis and other relevant testing will be performed to monitor children's HIV infection status. If the child is not infected, ART will be stopped when he/she reaches 6 weeks old. Otherwise, the treatment will be continued. Intervention group Nevirapine Children will receive antiretroviral treatment (ART) until 6 weeks old after birth. For the first two weeks, Zidovudine (AZT), Lamivudine (3TC) and Nevirapine (NVP) will be used. When the child is 2 weeks old, the regimen will be adjusted and Nevirapine (NVP) will be replaced by Lopinavir/ritonavir (LPV/r). Early infant diagnosis and other relevant testing will be performed to monitor children's HIV infection status. If the child is not infected, ART will be stopped when he/she reaches 6 weeks old. Otherwise, the treatment will be continued. Intervention group Zidovudine Children will receive antiretroviral treatment (ART) until 6 weeks old after birth. For the first two weeks, Zidovudine (AZT), Lamivudine (3TC) and Nevirapine (NVP) will be used. When the child is 2 weeks old, the regimen will be adjusted and Nevirapine (NVP) will be replaced by Lopinavir/ritonavir (LPV/r). Early infant diagnosis and other relevant testing will be performed to monitor children's HIV infection status. If the child is not infected, ART will be stopped when he/she reaches 6 weeks old. Otherwise, the treatment will be continued. Intervention group Lamivudine Children will receive antiretroviral treatment (ART) until 6 weeks old after birth. For the first two weeks, Zidovudine (AZT), Lamivudine (3TC) and Nevirapine (NVP) will be used. When the child is 2 weeks old, the regimen will be adjusted and Nevirapine (NVP) will be replaced by Lopinavir/ritonavir (LPV/r). Early infant diagnosis and other relevant testing will be performed to monitor children's HIV infection status. If the child is not infected, ART will be stopped when he/she reaches 6 weeks old. Otherwise, the treatment will be continued. Control group Zidovudine Children will receive routine prevention of mother-to-child transmission of HIV services. Nevirapine (NVP) or Zidovudine (AZT) will be administrated to them until 6 weeks old after birth. Early infant diagnosis services will be provided when the child is 6 weeks old and repeated when 3 months old. Children with HIV infection will be referred to receive routine HIV infection treatment. Control group Nevirapine Children will receive routine prevention of mother-to-child transmission of HIV services. Nevirapine (NVP) or Zidovudine (AZT) will be administrated to them until 6 weeks old after birth. Early infant diagnosis services will be provided when the child is 6 weeks old and repeated when 3 months old. Children with HIV infection will be referred to receive routine HIV infection treatment.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (5)
Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
🇨🇳Nanning, Guangxi, China
Maternal and Child Health Hospital of Guangdong Province
🇨🇳Guangzhou, Guangdong, China
Maternal and Child Health Hospital of Xinjiang Uygur Autonomous Region
🇨🇳Urumqi, Xinjiang, China
Maternal and Child Health Hospital of Yunan Province
🇨🇳Kunming, Yunnan, China
Maternal and Child Health Hospital of Sichuan Province
🇨🇳Chengdu, Sichuan, China