Antiretroviral Regime for Viral Eradication in Newborns

Study Overview
=================
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.

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

Conditions
-----------------
HIV/AIDS and Infections

Intervention / Treatment
-----------------
* Drug: Zidovudine
* Drug: Nevirapine
* Drug: Lamivudine
* Drug: Lopinavir/ritonavir


Participation Criteria
=================
Eligibility 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 .

Ages Eligible for Study
-----------------
Minimum Age: 0 Days
Maximum Age: 1 Day

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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<br>* Dose will be adjusted according to the child's weight.<br>* Other names: AZT;Drug: Nevirapine<br>* Dose will be adjusted according to the child's weight.<br>* Other names: NVP;Drug: Lamivudine<br>* Dose will be adjusted according to the child's weight.<br>* Other names: 3TC;Drug: Lopinavir/ritonavir<br>* Dose will be adjusted according to the child's weight.<br>* Other names: LPV/r;|
| Active Comparator: Control group<br>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<br>* Dose will be adjusted according to the child's weight.<br>* Other names: AZT;Drug: Nevirapine<br>* Dose will be adjusted according to the child's weight.<br>* 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
testing, HIV, antiretroviral treatment, child