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Antiretroviral Regime for Viral Eradication in Newborns

This study is currently recruiting participants.
Verified September 2016 by Xi JIN, National Center for Women and Children's Health, China CDC
Sponsor:
ClinicalTrials.gov Identifier:
NCT02712801
First Posted: March 18, 2016
Last Update Posted: September 27, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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
  Purpose
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 Intervention Phase
HIV/AIDS and Infections Drug: Zidovudine Drug: Nevirapine Drug: Lamivudine Drug: Lopinavir/ritonavir Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Xi JIN, National Center for Women and Children's Health, China CDC:

Primary Outcome Measures:
  • HIV infection in children [ Time Frame: 0-18 months old ]
    Number of children diagnosed with HIV infection

  • Functional HIV cure in children [ Time Frame: 0-36 months old ]
    Number of children with functional HIV cure


Secondary Outcome Measures:
  • Mortality [ Time Frame: 0-36 months old ]
    Number of children died

  • 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

  • Testing algorithm for early infant diagnosis of HIV [ Time Frame: 0-4 weeks old ]
    Testing methods and algorithm for HIV exposed infants


Estimated Enrollment: 600
Study Start Date: April 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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.


Ages Eligible for Study:   up 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
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


Contacts
Contact: Ailing Wang, M.D. 0086-10-62170944 ailing@chinawch.org.cn
Contact: Lixia Dou, Ph.D. 0086-10-62170948 doulx@chinawch.org.cn

Locations
China, Guangdong
Maternal and Child Health Hospital of Guangdong Province Recruiting
Guangzhou, Guangdong, China
Contact: Jiying Wen         
China, Guangxi
Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region Recruiting
Nanning, Guangxi, China
Contact: Xiaoxia Qiu         
China, Sichuan
Maternal and Child Health Hospital of Sichuan Province Recruiting
Chengdu, Sichuan, China
Contact: Gang Zhang         
China, Xinjiang
Maternal and Child Health Hospital of Xinjiang Uygur Autonomous Region Recruiting
Urumqi, Xinjiang, China
Contact: Lei Wang         
China, Yunnan
Maternal and Child Health Hospital of Yunan Province Recruiting
Kunming, Yunnan, China
Contact: Yan Zhang         
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
Principal Investigator: Xi Jin, M.D. National Center for Women and Children's Health, China CDC
  More Information

Responsible Party: Xi JIN, Deputy Director, National Center for Women and Children's Health, China CDC
ClinicalTrials.gov Identifier: NCT02712801     History of Changes
Other Study ID Numbers: 2015ZX10001001
First Submitted: March 14, 2016
First Posted: March 18, 2016
Last Update Posted: September 27, 2016
Last Verified: September 2016
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:
Ritonavir
Lopinavir
Lamivudine
Zidovudine
Nevirapine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Antimetabolites
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers


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