Skip to content

Long-term cohort study of efficacy and changes in metabolism-related markers of switching to an enovrin-containing regimen in HIV-1-positive treated patients due to dyslipidemia or weight gain

Long-term cohort study of efficacy and changes in metabolism-related markers of switching to an enovrin-containing regimen in HIV-1-positive treated patients due to dyslipidemia or weight gain

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500099875
Enrollment
Unknown
Registered
2025-03-31
Start date
2024-03-25
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

HIV

Interventions

Observation group:NA

Sponsors

Chest Hospital of Guangxi Zhuang Autonomous Region
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >=18 years old; 2. Have been diagnosed as HIV-1 positive, have been on ART for more than 12 months, and have at least one HIV RNA at the lower limit of detection in the last six months; 3. Patients with dyslipidemia or borderline elevated blood lipids in at least one of the four measures, abnormal weight increase within 1-2 years after the start of ART, or body mass index (BMI) >=24 kg/m2, were judged by the investigators to be suitable for conversion to ANV-containing therapy; 4. Able to understand and comply with the requirements of the study protocol and voluntarily sign a written informed consent;

Exclusion criteria

Exclusion criteria: 1. Previous drug resistance results showed the presence of non-nucleoside drugs, lamivudine, tenofovir resistance mutations; 2. In the course of previous treatment, there was a change of treatment schedule due to failure of non-nucleoside drugs; 3. Any severe metabolic disease judged by the investigator to be unsuitable for the study; 4. Have major mental illness such as schizophrenia, epilepsy, major depression/anxiety; 5. Is currently suffering from AIDS related diseases and accept through CYP2C19 metabolism of drugs; 6. Have a history of drug use, recent history of alcohol or drug dependence; 7. Any condition that the investigator believes may compromise the safety of the subject and affect adherence to the protocol; 8. Participants who participated in clinical trials of other drugs or therapeutic devices within 30 days prior to enrollment in the study; 9. Systemic immunosuppressive therapy or immunomodulators were used within 30 days prior to treatment in this study, or users could not be avoided during the clinical trial; 10. Alanine aminotransferase or aspartase > 5×ULN; 11. Creatinine >=1.5×ULN or glomerular filtration rate (GFR) <=60ml/min/1.73 m^2 according to CKD-EPI creatinine formula; 12. Have a history of allergy or hypersensitivity to any ingredient or excipient of the investigational drug; Women who are pregnant or breastfeeding, and women of childbearing age who have a need to have a child within two years.

Design outcomes

Primary

MeasureTime frame
HIV RNA viral load detection;CD4 T cell count test;

Secondary

MeasureTime frame
Urea nitrogen;

Countries

China

Contacts

Public ContactHuang Wei

Chest Hospital of Guangxi Zhuang Autonomous Region

43909785@qq.com+86 772 3130307

Outcome results

None listed

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