Antiretroviral Regime for Viral Eradication in Newborns After Intervention Failure of Mother-to-child Transmission of HIV
| Registry | NCT02712801 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: none, prevention |
| Enrollment | 600 (Actual) |
| Sponsor | National Center for Women and Children's Health, China CDC (Other gov); 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 |
| Conditions | HIV/AIDS and Infections |
| Interventions | Zidovudine, Nevirapine, Lamivudine, Lopinavir/ritonavir (Drug) |
| Dates | start 2016-04-01, primary completion 2021-12-01, completion 2021-12-01, first posted 2016-03-18, last updated 2022-09-28 |
| Locations | 5 sites in China |
Related Papers Related Patents Related Grants Related Experts
All trials for HIV/AIDS and Infections All trials of Zidovudine All trials of Nevirapine
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Intervention group | Experimental | Drug: Zidovudine; Drug: Nevirapine; Drug: Lamivudine; Drug: Lopinavir/ritonavir | 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. |
| Control group | Active comparator | Drug: Zidovudine; Drug: Nevirapine | 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. |
Sex: All, ages: 0 Days to 1 Day
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 .
| Facility | City | Country | Status |
|---|---|---|---|
| Maternal and Child Health Hospital of Guangdong Province | Guangzhou, Guangdong | China | |
| Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region | Nanning, Guangxi | China | |
| Maternal and Child Health Hospital of Sichuan Province | Chengdu, Sichuan | China | |
| Maternal and Child Health Hospital of Xinjiang Uygur Autonomous Region | Ürümqi, Xinjiang | China | |
| Maternal and Child Health Hospital of Yunan Province | Kunming, Yunnan | China |