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Completed

NCT Number: NCT02712801

Antiretroviral Regime for Viral Eradication in Newborns

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.

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Key information

Conditions

HIV/AIDS and Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

0 day–1 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Maternal and Child Health Hospital of Guangdong Province, Guangzhou, Guangdong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Zidovudine

Drug

Dose will be adjusted according to the child's weight.

Other names: AZT

Nevirapine

Drug

Dose will be adjusted according to the child's weight.

Other names: NVP

Lamivudine

Drug

Dose will be adjusted according to the child's weight.

Other names: 3TC

Lopinavir/ritonavir

Drug

Dose will be adjusted according to the child's weight.

Other names: LPV/r

Primary outcomes

  1. HIV infection in children

    Time frame: 0-18 months old

    Number of children diagnosed with HIV infection

  2. Functional HIV cure in children

    Time frame: 0-36 months old

    Number of children with functional HIV cure

Secondary outcomes

  1. Mortality

    Time frame: 0-36 months old

    Number of children died

  2. ART regime for HIV exposed children at high risk of infection

    Time frame: 0-36 months old

    ART regime to be used for functional HIV cure in children

  3. Testing algorithm for early infant diagnosis of HIV

    Time frame: 0-4 weeks old

    Testing methods and algorithm for HIV exposed infants

Sponsors and collaborators

Lead sponsor

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

Other Gov

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

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Mar 18, 2016
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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