drugset / Trial / NCT02712801
Antiretroviral Regime for Viral Eradication in Newborns
Phase 4
Completed
600 enrolled
National Center for Women and Children's Health, China CDC
Guangdong Provincial Maternal and Child Health Hospital · collabMaternal and Child Health Hospital of Guangxi Province · collabMaternal and Child Health Hospital of Sichuan Province · collabMaternal and Child Health Hospital of Xinjiang Uygur Autonomous Region · collabMaternal and Child Health Hospital of Yunan Province · collabNational Center for AIDS/STD Control and Prevention, China CDC · collab
RandomizedParallel-groupOpen-labelPrevention
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.
Timeline
- Start
- 2016-04
- Primary completion
- 2021-12
- Completion
- 2021-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lamivudine | Other / unclassified | — | — |
| Subject | Lopinavir/ritonavir | Unknown | — | — |
| Subject | Nevirapine | Small molecule | — | — |
| Subject | Zidovudine | Small molecule | — | — |