Antiretroviral Regime for Viral Eradication in Newborns

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

Status and phase: Completed; Phase 4

Conditions: HIV/AIDS and Infections

Treatments: Drug: Zidovudine; Drug: Lamivudine; Drug: Lopinavir/ritonavir; Drug: Nevirapine

Study type: Interventional

Funder types: Other

Identifiers

NCT02712801

2015ZX10001001

Details and patient eligibility

About

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.

Enrollment: 600 patients

Sex: All

Ages: Under 1 day old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Drug: Nevirapine

Drug: Lopinavir/ritonavir

Drug: Lamivudine

Drug: Zidovudine

Control group

Active Comparator group

Description:

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.

Treatment:

Drug: Nevirapine

Drug: Zidovudine