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Effects of the ANV/3TC/TDF on Lipid Metabolism in Virologically Suppressed People Living with HIV with LDL-C>= 3 mmol/L: A Multicenter Prospective Observational Cohort Study

Effects of the ANV/3TC/TDF on Lipid Metabolism in Virologically Suppressed People Living with HIV with LDL-C>= 3 mmol/L: A Multicenter Prospective Observational Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600116789
Enrollment
Unknown
Registered
2026-01-15
Start date
2025-09-09
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Patients confirmed as HIV-positive with reference to the Chinese Guidelines for HIV/AIDS Diagnosis and Treatment (2024 Edition) and verified by the Center for Disease Control and Prevention

Interventions

Patient group planned for conversion to the AINOMITI regimen:None

Sponsors

Southern Medical University Southern Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Voluntarily signed informed consent form; 2. Age >= 18 years, gender unrestricted; 3. Patients confirmed as HIV-infected according to the "Chinese Guidelines for HIV/AIDS Diagnosis and Treatment (2024 Edition)" by the Center for Disease Control and Prevention; 4. LDL-C >= 3.0 mmol/L (according to the European EACS Guidelines 12.0 recommendation that the treatment target for HIV-infected individuals is LDL-C < 3.0 mmol/L), i.e., patients requiring lipid intervention; 5. Patients on ART for more than one year with virologic suppression and a recent HIV-1 RNA < 40 copies/mL test result within the past six months; 6. Patients who, upon physician’s order, require conversion to the AINOMITI regimen based on clinical condition.

Exclusion criteria

Exclusion criteria: 1.History of NNRTI resistance (except for K103N, Y181C, L100I, or G190A mutations); 2.Frequent ART regimen changes (>=2 modifications in the past year); 3.Current use of lipid-lowering medications; 4.Deemed ineligible by investigators based on clinical judgment.

Design outcomes

Primary

MeasureTime frame
Routine Laboratory Examinations and Biochemical Parameters;Immunological and Virological Parameters;Examination Parameters;Metabolic Parameters;

Secondary

MeasureTime frame
Demographic Data;Medical History;Framingham score;Physical Examination Data;

Countries

China

Contacts

Public ContactPeng Jie

Southern Medical University Southern Hospital

pjie138@163.com+86 20 61641944

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026