Antiretroviral Regime for Viral Eradication in Newborns

NCT02712801 | Completed Phase 4 DMC

• 1 other identifier: 2015ZX10001001
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 5

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.

Conditions

HIV/AIDS and Infections

Keywords

HIV; antiretroviral treatment; child; testing

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Mortality

  0-36 months old

• ART regime for HIV exposed children at high risk of infection

  0-36 months old

• Testing algorithm for early infant diagnosis of HIV

  0-4 weeks old

Study Arms (2)

Intervention group

EXPERIMENTAL

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; Drug: Nevirapine; Drug: Lamivudine; Drug: Lopinavir/ritonavir

Control group

ACTIVE COMPARATOR

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; Drug: Nevirapine

Interventions

Zidovudine DRUG

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

Also known as: AZT

Control group; Intervention group

Nevirapine DRUG

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

Also known as: NVP

Control group; Intervention group

Lamivudine DRUG

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

Also known as: 3TC

Intervention group

Lopinavir/ritonavir DRUG

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

Also known as: LPV/r

Intervention group

Eligibility Criteria

• Age: 0 Days - 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children whose mother with HIV infection
• children whose mother received antiretroviral drugs after 36 gestational weeks or received no drugs before delivery
• live birth

You may not qualify if:

• 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 .

Sponsors & Collaborators

• National Center for Women and Children's Health, China CDC: lead
• National Center for AIDS/STD Control and Prevention, China CDC: collaborator
• Maternal and Child Health Hospital of Yunan Province: collaborator
• Maternal and Child Health Hospital of Sichuan Province: collaborator
• Maternal and Child Health Hospital of Guangxi Province: collaborator
• Maternal and Child Health Hospital of Xinjiang Uygur Autonomous Region: collaborator
• Guangdong Provincial Maternal and Child Health Hospital: collaborator

Study Sites (5)

Maternal and Child Health Hospital of Guangdong Province

Guangzhou, Guangdong, China

Location

Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

Location

Maternal and Child Health Hospital of Sichuan Province

Chengdu, Sichuan, China

Location

Maternal and Child Health Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, China

Location

Maternal and Child Health Hospital of Yunan Province

Kunming, Yunnan, China

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Infections

Interventions

Zidovudine; Nevirapine; Lamivudine; Lopinavir

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; 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

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pyridines; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidinones

Study Officials

• Xi Jin, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: March 18, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)