Trial | NCT02712801  Report issue

Title

Antiretroviral Regime for Viral Eradication in Newborns
Antiretroviral Regime for Viral Eradication in Newborns After Intervention Failure of Mother-to-child Transmission of HIV

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    600
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 Started
Apr 30
2016
Primary Completion
Dec 31
2021
Study Completion
Dec 31
2021
Last Update
Sep 28
2022

Drug Zidovudine

Dose will be adjusted according to the child's weight.

  • Other names: AZT

Drug Nevirapine

Dose will be adjusted according to the child's weight.

  • Other names: NVP

Drug Lamivudine

Dose will be adjusted according to the child's weight.

  • Other names: 3TC

Drug Lopinavir/ritonavir

Dose will be adjusted according to the child's weight.

  • Other names: LPV/r

Intervention group Experimental

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 Active Comparator

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.

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 .
No Results Posted