HIV InfectionsNCT05808803
Aberrant Myeloid Lineage Differentiation in HIV/AIDS Patients
An observational study of HIV Infections and Leukemia, run by Zhongnan Hospital.
Trial summary
The investigators included 782 HIV-infected patients from January 2016 to October 2020 Zhongnan Hospital of Wuhan University, whose AIDS diagnosis criteria met the "AIDS Diagnosis and Treatment Guide (2018 edition)" of Chinese Medical Association. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infections, Leukemia
- How many people
- 782 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Jan 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The investigators included 782 HIV-infected patients from January 2016 to October 2020 Zhongnan Hospital of Wuhan University, whose AIDS diagnosis criteria met the "AIDS Diagnosis and Treatment Guide (2018 edition)" of Chinese Medical Association. There were 647 male patients and 135 female patients, aged 14-78 years, with an average age of 43 years.
Who may be able to join
- HIV-infection
Who cannot join
- -
About this study
Official title: A Single-center, Retrospective Cohort Study of Aberrant Myeloid Lineage Differentiation in HIV/AIDS Patients
The investigators included 782 HIV-infected patients from January 2016 to October 2020 Zhongnan Hospital of Wuhan University, whose AIDS diagnosis criteria met the "AIDS Diagnosis and Treatment Guide (2018 edition)" of Chinese Medical Association.
- Conditions
- HIV Infections, Leukemia
- Medical subject headings
- HIV Infections, Leukemia
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 |
|---|---|---|
| HIV without leukemia | Not described | |
| HIV leukemia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of granulocytes and granulocyte/macrophage progenitors in myelogram of HIV/AIDS patients
Flow cytometric immunophenotyping of an EDTA-anticoagulated BM aspirate specimen was performed. A standard BM assay with erythrocyte cell lysis was used for all BM aspirate specimens. Flow cytometric analysis was conducted using a FACS Canto II flow cytometer (Becton Dickinson, Sunnyvale, CA, USA).
Measured: 2020
Secondary outcomes (1)
Neutrophil counts in peripheral blood of HIV/AIDS patients
Blood samples were drawn from patients undergoing routine diagnostic blood analysis at our institute by sterile venipuncture into tubes containing 5.4 mg of K2EDTA and analyzed by the automated hematology analyzer.
Measured: 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start1 Jan 2016
- Primary completion31 Oct 2020
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 782 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808803
- Sponsor's protocol ID
- 05
- Status last verified
- Jan 2023
- First submitted
- 10 Feb 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Retrospective Cohort Study of Aberrant Myeloid Lineage Differentiation in HIV/AIDS Patients
- ClinicalTrials.gov ID
- NCT05808803
- Acronym / sponsor ID
- 05
- Conditions
- HIV Infections, Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 782 participants (actual)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 11 Apr 2023 (actual)
- 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.
The investigators included 782 HIV-infected patients from January 2016 to October 2020 Zhongnan Hospital of Wuhan University, whose AIDS diagnosis criteria met the "AIDS Diagnosis and Treatment Guide (2018 edition)" of Chinese Medical Association.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV without leukemia | – | – |
| HIV leukemia | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The investigators included 782 HIV-infected patients from January 2016 to October 2020 Zhongnan Hospital of Wuhan University, whose AIDS diagnosis criteria met the "AIDS Diagnosis and Treatment Guide (2018 edition)" of Chinese Medical Association. There were 647 male patients and 135 female patients, aged 14-78 years, with an average age of 43 years.
Key inclusion criteria (1 listed)
- HIV-infection
Key exclusion criteria (1 listed)
- -
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 proportion of granulocytes and granulocyte/macrophage progenitors in myelogram of HIV/AIDS patients
Time frame: 2020
Flow cytometric immunophenotyping of an EDTA-anticoagulated BM aspirate specimen was performed. A standard BM assay with erythrocyte cell lysis was used for all BM aspirate specimens. Flow cytometric analysis was conducted using a FACS Canto II flow cytometer (Becton Dickinson, Sunnyvale, CA, USA).
1 secondary outcome
Neutrophil counts in peripheral blood of HIV/AIDS patients
Time frame: 2020
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 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Leukemia, run by Zhongnan Hospital.
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 1 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 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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 proportion of granulocytes and granulocyte/macrophage progenitors in myelogram of HIV/AIDS patients (time frame: 2020). 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 2023.