Antiretroviral Regime for Viral Eradication in Newborns

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

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.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS and Infections
• Intervention / Treatment: Drug: Zidovudine; Drug: Nevirapine; Drug: Lamivudine; Drug: Lopinavir/ritonavir

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Maternal and Child Health Hospital of Guangdong Province
  • Guangxi
    • Nanning, Guangxi, China
      • Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
  • Sichuan
    • Chengdu, Sichuan, China
      • Maternal and Child Health Hospital of Sichuan Province
  • Xinjiang
    • Urumqi, Xinjiang, China
      • Maternal and Child Health Hospital of Xinjiang Uygur Autonomous Region
  • Yunnan
    • Kunming, Yunnan, China
      • Maternal and Child Health Hospital of Yunan Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 1 day (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: AZT; Drug: Nevirapine; Dose will be adjusted according to the child's weight.; Other Names: NVP; Drug: Lamivudine; Dose will be adjusted according to the child's weight.; Other Names: 3TC; Drug: Lopinavir/ritonavir; Dose will be adjusted according to the child's weight.; Other Names: 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 Names: AZT; Drug: Nevirapine; Dose will be adjusted according to the child's weight.; Other Names: NVP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV infection in children	Number of children diagnosed with HIV infection	0-18 months old
Functional HIV cure in children	Number of children with functional HIV cure	0-36 months old

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Number of children died	0-36 months old
ART regime for HIV exposed children at high risk of infection	ART regime to be used for functional HIV cure in children	0-36 months old
Testing algorithm for early infant diagnosis of HIV	Testing methods and algorithm for HIV exposed infants	0-4 weeks old

Collaborators and Investigators

• Sponsor: National Center for Women and Children's Health, China CDC
• Collaborators: National Center for AIDS/STD Control and Prevention, China CDC; Guangdong Provincial Maternal and Child Health Hospital; Maternal and Child Health Hospital of Xinjiang Uygur Autonomous Region; Maternal and Child Health Hospital of Yunan Province; Maternal and Child Health Hospital of Sichuan Province; Maternal and Child Health Hospital of Guangxi Province
• Investigators: Principal Investigator: Xi Jin, M.D., National Center for Women and Children's Health, China CDC

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: March 14, 2016
• First Submitted That Met QC Criteria: March 14, 2016
• First Posted (Estimate): March 18, 2016

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: HIV; antiretroviral treatment; child; testing
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Antimetabolites; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; HIV Protease Inhibitors; Viral Protease Inhibitors; Nevirapine; Ritonavir; Lopinavir; Lamivudine; Zidovudine
• Other Study ID Numbers: 2015ZX10001001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No