Antiretroviral Regime for Viral Eradication in Newborns

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Women and Children's Health, China CDC
• Collaborators: Guangdong Provincial Maternal and Child Health Hospital; Maternal and Child Health Hospital of Guangxi Province; Maternal and Child Health Hospital of Sichuan Province; Maternal and Child Health Hospital of Xinjiang Uygur Autonomous Region; Maternal and Child Health Hospital of Yunan Province; National Center for AIDS/STD Control and Prevention, China CDC
• Treatments: Lamivudine; Lopinavir; Nevirapine; Ritonavir; Zidovudine

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 .