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Prospective Observational Cohort Study on the Metabolic Effects of Different ART Regimens in Chinese HIV-Infected Individuals

Prospective Observational Cohort Study on the Metabolic Effects of Different ART Regimens in Chinese HIV-Infected Individuals

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600124427
Enrollment
Unknown
Registered
2026-05-12
Start date
2025-08-04
Completion date
Unknown
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AIDS

Interventions

Sponsors

Shanghai Public Health Clinical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >= 18 years old; 2.Confirmed HIV infection and initiation of ART for >= 6 month; 3.Not diagnosed with MetS at baseline; 4.Individuals who can understand and comply with the requirements of the research protocol and voluntarily sign a written informed consent form;

Exclusion criteria

Exclusion criteria: 1.Complicated with severe opportunistic infections (such as active tuberculosis, cryptococcal meningitis) or tumors; 2.Suffering from major neurological and psychiatric diseases such as schizophrenia, epilepsy, and severe depression/anxiety; 3.People with a history of drug abuse or a recent history of alcohol or drug dependence; 4.People with a history of allergies to any ingredient or excipient of the study drug, or those with a hypersensitive constitution. 5.Pregnant or lactating women; women of childbearing age who have not adopted contraceptive measures considered effective by the researcher (such as diaphragms, condoms, intrauterine devices, etc.; partner's vasectomy); 6.Individuals in the active phase of infectious diseases, the acute phase of severe cardiovascular diseases, or other conditions that the researcher deems unsuitable for participation in the study; 7.Baseline eGFR < 60 mL/min/1.73m^2 or a history of diabetes; 8.Individuals deemed unsuitable for participation in the study by the researcher for other reasons (such as contraindicated populations and unsuitable populations specified in the instruction manual, etc.);

Design outcomes

Primary

MeasureTime frame
Incidence of metabolic syndrome (MetS) in HIV-infected individuals in different subgroups receiving various ART regimens, and changes in metabolism-related indicators (abdominal obesity, blood pressure, fasting blood glucose, TG, HDL-C);

Secondary

MeasureTime frame
Changes in metabolism-related indicators (abdominal obesity, blood pressure, fasting blood glucose, TG, HDL-C);The proportion of patients with HIV RNA <50 copies/ml, and the changes from baseline in CD4 T cells, CD8 T cells, and the CD4/CD8 ratio;Proportion of antiviral treatment failure, therapy regimen change, and patient adherence;Changes in liver and kidney function compared to baseline;Incidence of adverse events (AE);

Countries

China

Contacts

Public ContactShen Yinzhong

Shanghai Public Health Clinical Center

shenyinzhong@shphc.org.cn+86 21 37990333

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026