Antiretroviral Regime for Viral Eradication in Newborns

HIV/AIDS and Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02712801
• Other study ID #: 2015ZX10001001
• Status: Completed
• Phase: Phase 4
• Start date: April 2016
• Est. completion date: December 2021

Study information

• Verified date: September 2022
• Source: National Center for Women and Children's Health, China CDC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 1 Day

Eligibility

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 .

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS and Infections

Intervention

Drug:
• Zidovudine
Dose will be adjusted according to the child's weight.
• Nevirapine
Dose will be adjusted according to the child's weight.
• Lamivudine
Dose will be adjusted according to the child's weight.
• Lopinavir/ritonavir
Dose will be adjusted according to the child's weight.

Locations

Country	Name	City	State
China	Maternal and Child Health Hospital of Sichuan Province	Chengdu	Sichuan
China	Maternal and Child Health Hospital of Guangdong Province	Guangzhou	Guangdong
China	Maternal and Child Health Hospital of Yunan Province	Kunming	Yunnan
China	Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region	Nanning	Guangxi
China	Maternal and Child Health Hospital of Xinjiang Uygur Autonomous Region	Urumqi	Xinjiang

Sponsors (7)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV infection in children	Number of children diagnosed with HIV infection	0-18 months old
Primary	Functional HIV cure in children	Number of children with functional HIV cure	0-36 months old
Secondary	Mortality	Number of children died	0-36 months old
Secondary	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
Secondary	Testing algorithm for early infant diagnosis of HIV	Testing methods and algorithm for HIV exposed infants	0-4 weeks old