An observational study in HIV (Human Immunodeficiency Virus), AIDS and Kaposi Sarcoma (KS), sponsored by Shenzhen Third People's Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Shenzhen Third People's Hospital · Observational
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.
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.
Exclusion Criteria:
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.
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.
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).
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.
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).
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome→
Shenzhen Third People's Hospital