NCT02712801

Antiretroviral Regime for Viral Eradication in Newborns

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: National Center for Women and Children's Health, China CDC · Other Government
• Sex: All
• Age: 0 Days – 1 Day
• Healthy volunteers: Not accepted

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.

Conditions

• HIV/AIDS and Infections

Interventions

Type	Name	Description
DRUG	Zidovudine	Dose will be adjusted according to the child's weight.
DRUG	Nevirapine	Dose will be adjusted according to the child's weight.
DRUG	Lamivudine	Dose will be adjusted according to the child's weight.
DRUG	Lopinavir/ritonavir	Dose will be adjusted according to the child's weight.

Timeline

• Start date: 2016-04-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2016-03-18
• Last updated: 2022-09-28

Locations

5 sites across 1 country: China