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| Name | Class |
|---|---|
| National Center for AIDS/STD Control and Prevention, China CDC | OTHER_GOV |
| Maternal and Child Health Hospital of Yunan Province | UNKNOWN |
| Maternal and Child Health Hospital of Sichuan Province | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zidovudine | Drug | Dose will be adjusted according to the child's weight. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xi Jin, M.D. | National Center for Women and Children's Health, China CDC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternal and Child Health Hospital of Guangdong Province | Guangzhou | Guangdong | China | |||
| Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 21, 2024 | |
| Reset | Aug 16, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 21, 2024 | Aug 16, 2024 |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D007239 | Infections |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D015215 | Zidovudine |
| D019829 | Nevirapine |
| D019259 | Lamivudine |
| D061466 | Lopinavir |
| ID | Term |
|---|---|
| D013936 | Thymidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Maternal and Child Health Hospital of Guangxi Province | UNKNOWN |
| Maternal and Child Health Hospital of Xinjiang Uygur Autonomous Region | UNKNOWN |
| Guangdong Provincial Maternal and Child Health Hospital | OTHER |
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| Nevirapine | Drug | Dose will be adjusted according to the child's weight. |
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| Lamivudine | Drug | Dose will be adjusted according to the child's weight. |
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| Lopinavir/ritonavir | Drug | Dose will be adjusted according to the child's weight. |
|
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| 0-36 months old |
| Testing algorithm for early infant diagnosis of HIV | Testing methods and algorithm for HIV exposed infants | 0-4 weeks old |
| 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 |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006571 |
| Heterocyclic Compounds |
| D015224 | Dideoxynucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011725 | Pyridines |
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011744 | Pyrimidinones |