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Antiretroviral Regime for Viral Eradication in Newborns

NCT02712801 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2022-09-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • National Center for AIDS/STD Control and Prevention, China CDC

    collaborator OTHER_GOV

  • Maternal and Child Health Hospital of Yunan Province

    collaborator UNKNOWN

  • Maternal and Child Health Hospital of Sichuan Province

    collaborator UNKNOWN

  • Maternal and Child Health Hospital of Guangxi Province

    collaborator UNKNOWN

  • Maternal and Child Health Hospital of Xinjiang Uygur Autonomous Region

    collaborator UNKNOWN

  • Guangdong Provincial Maternal and Child Health Hospital

    collaborator OTHER

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

    lead OTHER_GOV

Principal Investigators

  • Xi Jin, M.D. · National Center for Women and Children's Health, China CDC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
1 Day
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02712801 on ClinicalTrials.gov