Antiretroviral Regime for Viral Eradication in Newborns

Sponsor

National Center for Women and Children's Health, China CDC (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02712801

Collaborator

National Center for AIDS/STD Control and Prevention, China CDC (Other), Maternal and Child Health Hospital of Yunan Province (Other), Maternal and Child Health Hospital of Sichuan Province (Other), Maternal and Child Health Hospital of Guangxi Province (Other), Maternal and Child Health Hospital of Xinjiang Uygur Autonomous Region (Other), Guangdong Provincial Maternal and Child Health Hospital (Other)

600

Enrollment

Locations

Arms

Anticipated Duration (Months)

120

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV/AIDS and Infections	Drug: Zidovudine Drug: Nevirapine Drug: Lamivudine Drug: Lopinavir/ritonavir	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group 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.	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
Active Comparator: Control group 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.	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

Arm

Intervention/Treatment

Experimental: Intervention group

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.

Drug: Zidovudine