HIV/AIDS and InfectionsPhase 4NCT02712801
Antiretroviral Regime for Viral Eradication in Newborns
A Phase 4 study testing Zidovudine, Nevirapine and Lamivudine in people with HIV/AIDS and Infections, run by National Center for Women and Children's Health, China CDC at 5 sites in China.
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. Read more about this study
- Who is it for?
- Ages 0 days to 1 day
- Conditions the study is for
- HIV/AIDS and Infections
- What is being tested?
- Zidovudine, Nevirapine and Lamivudine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 5 sitesChina
- Study dates
- Apr 2016to Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children whose mother with HIV infection
- children whose mother received antiretroviral drugs after 36 gestational weeks or received no drugs before delivery
- live birth
Who cannot join
- 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 .
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Maternal and Child Health Hospital of Sichuan Province
Chengdu, Sichuan
Maternal and Child Health Hospital of Guangdong Province
Guangzhou, Guangdong
Maternal and Child Health Hospital of Yunan Province
Kunming, Yunnan
Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi
Maternal and Child Health Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang
About this study
Official title: Antiretroviral Regime for Viral Eradication in Newborns After Intervention Failure of Mother-to-child Transmission of HIV
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.
- Conditions
- HIV/AIDS and Infections
- Being tested
- Zidovudine, Nevirapine, Lamivudine, Lopinavir/ritonavir
- Keywords
- HIV, antiretroviral treatment, child, testing
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZidovudineDrug
Also called AZT
Dose will be adjusted according to the child's weight.
NevirapineDrug
Also called NVP
Dose will be adjusted according to the child's weight.
LamivudineDrug
Also called 3TC
Dose will be adjusted according to the child's weight.
Lopinavir/ritonavirDrug
Also called LPV/r
Dose will be adjusted according to the child's weight.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Zidovudine; Drug: Nevirapine; Drug: Lamivudine; Drug: Lopinavir/ritonavir |
| 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. Receives: Drug: Zidovudine; Drug: Nevirapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV infection in children
Number of children diagnosed with HIV infection
Measured: 0-18 months old
Functional HIV cure in children
Number of children with functional HIV cure
Measured: 0-36 months old
Secondary outcomes (3)
Mortality
Number of children died
Measured: 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
Measured: 0-36 months old
Testing algorithm for early infant diagnosis of HIV
Testing methods and algorithm for HIV exposed infants
Measured: 0-4 weeks old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDS and InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Women and Children's Health, China CDC
- Sponsor type
- Other government
- 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
- Responsible party
- Principal investigator, Xi JIN, National Center for Women and Children's Health, China CDC
- Investigators
- Xi Jin, M.D., Principal investigator, National Center for Women and Children's Health, China CDC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712801
- Sponsor's protocol ID
- 2015ZX10001001
- Status last verified
- Sep 2022
- First submitted
- 14 Mar 2016
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiretroviral Regime for Viral Eradication in Newborns After Intervention Failure of Mother-to-child Transmission of HIV
- ClinicalTrials.gov ID
- NCT02712801
- Acronym / sponsor ID
- 2015ZX10001001
- Conditions
- HIV/AIDS and Infections
- Keywords
- HIV, antiretroviral treatment, child, testing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- National Center for Women and Children's Health, China CDCOther government
- 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
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 18 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Zidovudine, Drug: Nevirapine, Drug: Lamivudine, Drug: Lopinavir/ritonavirChildren 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: NevirapineChildren 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. |
Who may qualify
- Ages
- 0 days to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children whose mother with HIV infection
- children whose mother received antiretroviral drugs after 36 gestational weeks or received no drugs before delivery
- live birth
Key exclusion criteria (2 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZidovudineAlso: AZTDose will be adjusted according to the child's weight. | Drug | Control group, Intervention group |
| NevirapineAlso: NVPDose will be adjusted according to the child's weight. | Drug | Control group, Intervention group |
| LamivudineAlso: 3TCDose will be adjusted according to the child's weight. | Drug | Intervention group |
| Lopinavir/ritonavirAlso: LPV/rDose will be adjusted according to the child's weight. | Drug | Intervention group |
Primary outcome
HIV infection in children
Time frame: 0-18 months old
Number of children diagnosed with HIV infection
Functional HIV cure in children
Time frame: 0-36 months old
Number of children with functional HIV cure
3 secondary outcomes
Mortality
Time frame: 0-36 months old
ART regime for HIV exposed children at high risk of infection
Time frame: 0-36 months old
Testing algorithm for early infant diagnosis of HIV
Time frame: 0-4 weeks old
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xi Jin, M.D. principal investigator
National Center for Women and Children's Health, China CDC
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zidovudine, Nevirapine and Lamivudine in people with HIV/AIDS and Infections, run by National Center for Women and Children's Health, China CDC at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV infection in children (time frame: 0-18 months old). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.