Acquired Immunodeficiency SyndromeCN-PARTNCT01210924
Chinese Network of Pediatric Antiretroviral Therapy
An observational study of Acquired Immunodeficiency Syndrome, run by National Center for AIDS/STD Control and Prevention, China CDC at 1 site in China.
Trial summary
This is an observational cohort in pediatric HIV patients in China. Children who receive antiretroviral drugs will be recruited in this study. The main objectives are as follows: 1. To establish simpler and smarter pediatric antiretroviral therapy in China including both first-line and second-line regimens. 2. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Acquired Immunodeficiency Syndrome
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Apr 2010to Dec 2015
- Phase
- Observational
- 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 Up to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric HIV-infected patients receiving triple antiretroviral drugs
Who may be able to join
- clinical diagnosis of HIV infection
- receiving triple antiretroviral drugs
Who cannot join
- clinical status not stable
Trial locations and contacts
1 site in 1 country.
China1 site
National Center for AIDS/STD Control and Prevention, China Center for Disease Control and Prevention
Beijing, 102206
About this study
Official title: Chinese Study of Pediatric Antiretroviral Therapy
This is an observational cohort in pediatric HIV patients in China. Children who receive antiretroviral drugs will be recruited in this study. The main objectives are as follows: 1. To establish simpler and smarter pediatric antiretroviral therapy in China including both first-line and second-line regimens. 2. To study the nature, characteristics and mechanisms of immunoreconstitution in HIV-infected children using the data and samples from the pediatric antiretroviral therapy cohort. 3. To establish a basic science and clinical research network based on the pediatric antiretroviral cohort.
- Conditions
- Acquired Immunodeficiency Syndrome
- Keywords
- children, Acquired Immunodeficiency Syndrome, antiretroviral therapy, China, Mortality
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric ART patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The immunology and virologic outcomes
Measured: 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Immunodeficiency SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for AIDS/STD Control and Prevention, China CDC
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Fujie Zhang, MD, Principal investigator, National Center for AIDS/STD control and prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210924
- Sponsor's protocol ID
- Pediatric treatment 2010
- Other IDs
- 2008ZX10001-007
- Acronym
- CN-PART
- Status last verified
- Nov 2013
- First submitted
- 27 Sep 2010
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Study of Pediatric Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT01210924
- Acronym / sponsor ID
- CN-PART / Pediatric treatment 2010
- Conditions
- Acquired Immunodeficiency Syndrome
- Keywords
- children, Acquired Immunodeficiency Syndrome, antiretroviral therapy, China, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- National Center for AIDS/STD Control and Prevention, China CDCOther government
- Study start
- Apr 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Sep 2010 (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 an observational cohort in pediatric HIV patients in China. Children who receive antiretroviral drugs will be recruited in this study. The main objectives are as follows: 1. To establish simpler and smarter pediatric antiretroviral therapy in China including both first-line and second-line regimens. 2. To study the nature, characteristics and mechanisms of immunoreconstitution in HIV-infected children using the data and samples from the pediatric antiretroviral therapy cohort. 3. To establish a basic science and clinical research network based on the pediatric antiretroviral cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric ART patients | – | – |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric HIV-infected patients receiving triple antiretroviral drugs
Key inclusion criteria (2 listed)
- clinical diagnosis of HIV infection
- receiving triple antiretroviral drugs
Key exclusion criteria (1 listed)
- clinical status not stable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The immunology and virologic outcomes
Time frame: 2016
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 30 Mar 2018.
- Individual participant dataSharing planned: Undecided
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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.
Fujie Zhang, MD principal investigator
National Center for AIDS/STD control and prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acquired Immunodeficiency Syndrome, run by National Center for AIDS/STD Control and Prevention, China CDC at 1 site 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 2 inclusion and 1 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 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
The immunology and virologic outcomes (time frame: 2016). 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 30 Mar 2018.