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Antiretroviral Regime for Viral Eradication in Newborns

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02712801
Recruitment Status : Completed
First Posted : March 18, 2016
Last Update Posted : September 28, 2022
Sponsor:
Collaborators:
National Center for AIDS/STD Control and Prevention, China CDC
Maternal and Child Health Hospital of Yunan Province
Maternal and Child Health Hospital of Sichuan Province
Maternal and Child Health Hospital of Guangxi Province
Maternal and Child Health Hospital of Xinjiang Uygur Autonomous Region
Guangdong Provincial Maternal and Child Health Hospital
Information provided by (Responsible Party):
Xi JIN, National Center for Women and Children's Health, China CDC

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
HIV/AIDS and Infections Drug: Zidovudine Drug: Nevirapine Drug: Lamivudine Drug: Lopinavir/ritonavir Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Antiretroviral Regime for Viral Eradication in Newborns After Intervention Failure of Mother-to-child Transmission of HIV
Actual Study Start Date : April 2016
Actual Primary Completion Date : December 2021
Actual Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention group
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.
 Drug: Zidovudine
Dose will be adjusted according to the child's weight.
Other Name: AZT

Drug: Nevirapine
Dose will be adjusted according to the child's weight.
Other Name: NVP

Drug: Lamivudine
Dose will be adjusted according to the child's weight.
Other Name: 3TC

Drug: Lopinavir/ritonavir
Dose will be adjusted according to the child's weight.
Other Name: LPV/r
Active Comparator: Control group
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.
 Drug: Zidovudine
Dose will be adjusted according to the child's weight.
Other Name: AZT

Drug: Nevirapine
Dose will be adjusted according to the child's weight.
Other Name: NVP


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   0 Days to 1 Day   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 .
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02712801


Locations
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China, Guangdong
Maternal and Child Health Hospital of Guangdong Province
Guangzhou, Guangdong, China
China, Guangxi
Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
China, Sichuan
Maternal and Child Health Hospital of Sichuan Province
Chengdu, Sichuan, China
China, Xinjiang
Maternal and Child Health Hospital of Xinjiang Uygur Autonomous Region
Urumqi, Xinjiang, China
China, Yunnan
Maternal and Child Health Hospital of Yunan Province
Kunming, Yunnan, China
Sponsors and Collaborators
National Center for Women and Children's Health, China CDC
National Center for AIDS/STD Control and Prevention, China CDC
Maternal and Child Health Hospital of Yunan Province
Maternal and Child Health Hospital of Sichuan Province
Maternal and Child Health Hospital of Guangxi Province
Maternal and Child Health Hospital of Xinjiang Uygur Autonomous Region
Guangdong Provincial Maternal and Child Health Hospital
Investigators
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Principal Investigator: Xi Jin, M.D. National Center for Women and Children's Health, China CDC
More Information
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Layout table for additonal information
Responsible Party: Xi JIN, Deputy Director, National Center for Women and Children's Health, China CDC
ClinicalTrials.gov Identifier: NCT02712801    
Other Study ID Numbers: 2015ZX10001001
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: September 28, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Xi JIN, National Center for Women and Children's Health, China CDC:
HIV
antiretroviral treatment
child
testing
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Genital Diseases
Urogenital Diseases
Immunologic Deficiency Syndromes
 Immune System Diseases
Ritonavir
Lopinavir
Lamivudine
Zidovudine
Nevirapine
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents