HIV (Human Immunodeficiency Virus)NCT07696169
Disease Evolution and Risk Factors of AIDS-related Prevalent Cancers
An observational study of HIV (Human Immunodeficiency Virus) and AIDS, run by Shenzhen Third People's Hospital.
Trial summary
This study aims to investigate the disease progression trends and risk factors of common AIDS-related tumors, including Kaposi sarcoma, lymphoma, lung cancer, and et al., among people living with HIV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV (Human Immunodeficiency Virus), AIDS, Kaposi Sarcoma (KS)
- Type of treatment
- Pill or oral medicine
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll approximately 1 000 HIV-infected adults aged 18 years and older from 7 infectious disease treatment centers across China. Participants include individuals with confirmed AIDS who are receiving routine clinical care. The study employs an ambidirectional (retrospective-prospective) cohort design with a nested case-control analysis. The cohort comprises HIV-infected patients with and without AIDS-related malignancies (including Kaposi sarcoma, lymphoma, cervical cancer, anal cancer, oral cancer, colorectal cancer, and lung cancer). Within this cohort, cases are patients who developed malignancies during follow-up, and controls are matched HIV-infected patients without malignancies. The study population is intended to represent the broader demographic of adults living with HIV/AIDS under care in tertiary infectious disease centers in China.
Who may be able to join
- Age ≥ 18 years at the time of HIV diagnosis or study enrollment.
- Confirmed diagnosis of HIV-1 infection documented by positive serological testing (HIV antibody screening with confirmatory Western blot or HIV-1 RNA PCR).
- Confirmed HIV-1 infection based on established clinical and/or immunological criteria (e.g., CD4+ T-cell count < 200 cells/μL, or presence of AIDS-defining conditions).
- For the cohort phase: Received continuous or intermittent care at one of the participating centers with available baseline clinical data (CD4 count, HIV viral load, ART history) and at least 6 months of follow-up data.
- For the nested case-control analysis - Cases: Pathologically or clinically diagnosed with an AIDS-related malignancy during the study period, specifically one of the following: Kaposi sarcoma, lymphoma, cervical cancer, anal cancer, oral cancer, colorectal cancer, and lung cancer.
- For the nested case-control analysis - Controls: HIV-infected patients without a history of AIDS-related malignancy at the time of matching, selected from the same cohort using incidence density sampling.
- Able and willing to provide written informed consent for prospective data collection, medical record review, and follow-up (applicable to the prospective component).
Who cannot join
- Concurrent malignancy other than the study-specified AIDS-related malignancy (for cases); or presence of any AIDS-related malignancy (for controls).
- Systemic high-dose corticosteroid therapy (equivalent to prednisone ≥ 20 mg/day for ≥ 2 weeks) within 6 months prior to the index date.
- Severe comorbid systemic disease or major organ dysfunction (e.g., decompensated cirrhosis, New York Heart Association Class III-IV heart failure, severe chronic kidney disease with eGFR < 30 mL/min) that would independently limit survival or preclude study participation.
- Inability or unwillingness to comply with study procedures, including clinical data collection, biological specimen collection, and follow-up assessments.
- Pregnancy at the time of enrollment (for the prospective component only).
- Any other condition that, in the judgment of the investigator, would compromise the subject's ability to participate in the study or interfere with the interpretation of study results.
About this study
Official title: Analysis of Disease Evolution Trends and Risk Factors of AIDS-related High-incidence Tumors
This study aims to investigate the disease progression trends and risk factors of common AIDS-related tumors, including Kaposi sarcoma, lymphoma, lung cancer, and et al., among people living with HIV. By analyzing clinical data, the researchers hope to better understand how these cancers develop in HIV-infected patients and identify factors that may increase the risk. The findings may help improve early detection and treatment strategies for these cancers in the HIV population. This is an observational study, meaning participants will receive their usual medical care while researchers collect and analyze their health information. No experimental treatments will be given as part of this study.
- Conditions
- HIV (Human Immunodeficiency Virus), AIDS, Kaposi Sarcoma (KS), Lymphoma, AIDS-Related Malignancy, Lung Cancer in the HIV Patient
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sarcoma, Kaposi, Lymphoma, Uterine Cervical Neoplasms, Anus Neoplasms, Mouth Neoplasms, Colorectal Neoplasms
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 |
|---|---|---|
| Ambidirectional cohort of people living with HIV | A retrospective-prospective (ambidirectional) cohort of HIV-infected patients receiving care. The retrospective component analyzes historical clinical data to describe disease progression trends of AIDS-related malignancies (Kaposi sarcoma, lymphoma, cervical cancer, anal cancer, oral cancer, colorectal cancer, and lung cancer). The prospective component continues enrollment and follow-up of people living with HIV to capture new malignancy occurrences. Within this unified cohort, a nested case-control analysis will be conducted: cases are patients who develop AIDS-related malignancies, and controls are matched people living with HIV without malignancies selected from the same cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of AIDS-related malignancies
The proportion of HIV-infected patients who develop AIDS-related malignancies (Kaposi sarcoma, lymphoma, cervical cancer, anal cancer, oral cancer, colorectal cancer, and lung cancer) during the study period, calculated using Kaplan-Meier or competing risk methods.
Measured: From the date of HIV diagnosis to the date of first documented AIDS-related malignancy diagnosis, the date of death from any cause, or the end of the study period, whichever occurs first, assessed up to 10 years (120 months).
Independent risk factors for AIDS-related malignancy development
Odds ratios (ORs) and hazard ratios (HRs) of potential risk factors (baseline CD4 count, nadir CD4, HPV infection, ART duration, age, smoking history) for malignancy occurrence, derived from multivariable logistic regression and Cox proportional hazards models.
Measured: From the date of HIV diagnosis to the date of first documented AIDS-related malignancy diagnosis, the date of death from any cause, or the date of last follow-up, whichever occurs first, assessed up to 10 years (120 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV (Human Immunodeficiency Virus)Studies 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
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Third People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chongqing Public Health Medical Center, Xinjiang Uygur Autonomous Region Infectious Disease Hospital, Beijing Ditan Hospital, Fudan University, Guangzhou Eighth People's Hospital, Guangzhou Medical University., Nanfang Hospital, Southern Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696169
- Sponsor's protocol ID
- No. [2026-043-01]
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 10 Jul 2026
- 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 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Disease Evolution Trends and Risk Factors of AIDS-related High-incidence Tumors
- ClinicalTrials.gov ID
- NCT07696169
- Acronym / sponsor ID
- No. [2026-043-01]
- Conditions
- HIV (Human Immunodeficiency Virus), AIDS, Kaposi Sarcoma (KS), Lymphoma, AIDS-Related Malignancy, Lung Cancer in the HIV Patient
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shenzhen Third People's HospitalUniversity, hospital or other
- Collaborators
- Chongqing Public Health Medical Center, Xinjiang Uygur Autonomous Region Infectious Disease Hospital, Beijing Ditan Hospital, Fudan University, Guangzhou Eighth People's Hospital, Guangzhou Medical University., Nanfang Hospital, Southern Medical University
- Study start
- Jul 2026 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 10 Jul 2026 (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.
This study aims to investigate the disease progression trends and risk factors of common AIDS-related tumors, including Kaposi sarcoma, lymphoma, lung cancer, and et al., among people living with HIV. By analyzing clinical data, the researchers hope to better understand how these cancers develop in HIV-infected patients and identify factors that may increase the risk. The findings may help improve early detection and treatment strategies for these cancers in the HIV population. This is an observational study, meaning participants will receive their usual medical care while researchers collect and analyze their health information. No experimental treatments will be given as part of this study.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ambidirectional cohort of people living with HIV | – | –A retrospective-prospective (ambidirectional) cohort of HIV-infected patients receiving care. The retrospective component analyzes historical clinical data to describe disease progression trends of AIDS-related malignancies (Kaposi sarcoma, lymphoma, cervical cancer, anal cancer, oral cancer, colorectal cancer, and lung cancer). The prospective component continues enrollment and follow-up of people living with HIV to capture new malignancy occurrences. Within this unified cohort, a nested case-control analysis will be conducted: cases are patients who develop AIDS-related malignancies, and controls are matched people living with HIV without malignancies selected from the same cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll approximately 1 000 HIV-infected adults aged 18 years and older from 7 infectious disease treatment centers across China. Participants include individuals with confirmed AIDS who are receiving routine clinical care. The study employs an ambidirectional (retrospective-prospective) cohort design with a nested case-control analysis. The cohort comprises HIV-infected patients with and without AIDS-related malignancies (including Kaposi sarcoma, lymphoma, cervical cancer, anal cancer, oral cancer, colorectal cancer, and lung cancer). Within this cohort, cases are patients who developed malignancies during follow-up, and controls are matched HIV-infected patients without malignancies. The study population is intended to represent the broader demographic of adults living with HIV/AIDS under care in tertiary infectious disease centers in China.
Key inclusion criteria (7 listed)
- Age ≥ 18 years at the time of HIV diagnosis or study enrollment.
- Confirmed diagnosis of HIV-1 infection documented by positive serological testing (HIV antibody screening with confirmatory Western blot or HIV-1 RNA PCR).
- Confirmed HIV-1 infection based on established clinical and/or immunological criteria (e.g., CD4+ T-cell count < 200 cells/μL, or presence of AIDS-defining conditions).
- For the cohort phase: Received continuous or intermittent care at one of the participating centers with available baseline clinical data (CD4 count, HIV viral load, ART history) and at least 6 months of follow-up data.
- For the nested case-control analysis - Cases: Pathologically or clinically diagnosed with an AIDS-related malignancy during the study period, specifically one of the following: Kaposi sarcoma, lymphoma, cervical cancer, anal cancer, oral cancer, colorectal cancer, and lung cancer.
Key exclusion criteria (6 listed)
- Concurrent malignancy other than the study-specified AIDS-related malignancy (for cases); or presence of any AIDS-related malignancy (for controls).
- Systemic high-dose corticosteroid therapy (equivalent to prednisone ≥ 20 mg/day for ≥ 2 weeks) within 6 months prior to the index date.
- Severe comorbid systemic disease or major organ dysfunction (e.g., decompensated cirrhosis, New York Heart Association Class III-IV heart failure, severe chronic kidney disease with eGFR < 30 mL/min) that would independently limit survival or preclude study participation.
- Inability or unwillingness to comply with study procedures, including clinical data collection, biological specimen collection, and follow-up assessments.
- Pregnancy at the time of enrollment (for the prospective component only).
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
Cumulative incidence of AIDS-related malignancies
Time frame: From the date of HIV diagnosis to the date of first documented AIDS-related malignancy diagnosis, the date of death from any cause, or the end of the study period, whichever occurs first, assessed up to 10 years (120 months).
The proportion of HIV-infected patients who develop AIDS-related malignancies (Kaposi sarcoma, lymphoma, cervical cancer, anal cancer, oral cancer, colorectal cancer, and lung cancer) during the study period, calculated using Kaplan-Meier or competing risk methods.
Independent risk factors for AIDS-related malignancy development
Time frame: From the date of HIV diagnosis to the date of first documented AIDS-related malignancy diagnosis, the date of death from any cause, or the date of last follow-up, whichever occurs first, assessed up to 10 years (120 months).
Odds ratios (ORs) and hazard ratios (HRs) of potential risk factors (baseline CD4 count, nadir CD4, HPV infection, ART duration, age, smoking history) for malignancy occurrence, derived from multivariable logistic regression and Cox proportional hazards models.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
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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.
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 (Human Immunodeficiency Virus) and AIDS, run by Shenzhen Third People's 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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 10 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Cumulative incidence of AIDS-related malignancies (time frame: From the date of HIV diagnosis to the date of first documented AIDS-related malignancy diagnosis, the date of death from any cause, or the end of the study period, whichever occurs first, assessed up to 10 years (120 months).). 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 10 Jul 2026.