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Clinical study on the regimen containing ANV in HIV-1 positive patients over 50 years old in Guangxi

Clinical study on the regimen containing ANV in HIV-1 positive patients over 50 years old in Guangxi

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400084317
Enrollment
Unknown
Registered
2024-05-14
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-05-21

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

Conditions

HIV infection

Interventions

Sponsors

Nanning Fourth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 99 Years

Inclusion criteria

Inclusion criteria: (1) Aged =50 years (2) Diagnosed HIV-1 infection, previously treated with ARVs for more than 12 months and have had at least one HIV RNA <50 copies/ml in the last six months (3) Elevated or borderline elevated lipids in at least one of the four lipid profiles following Initiation of Antiretroviral Therapy (4) The researchers judged that swith to ANV/3TC/TDF therapy was suitable (5) Understand and comply with the requirements of the study protocol and voluntarily sign a written informed consent form.

Exclusion criteria

Exclusion criteria: (1) Presence of resistance mutations to non-nucleoside drugs, lamivudine and tenofovir (2) History of NNRTI failure or switch to another regimen (3) any severe chronic disease, metabolic disease, cardiovascular disease (4) Suffering from major mental illnesses such as schizophrenia, epilepsy, severe depression/anxiety, etc; (5). During the acute infection period of HIV-1 or currently suffering from AIDS related diseases; (6). Alanine aminotransferase or aspartate aminotransferase>5 * ULN; (7) History of diagnosis of osteoporosis or osteopenia (8))Hemoglobin (Hb) =10 g/dL for males and =9 g/dL for females (9) Creatinine =1.5×ULN or glomerular filtration rate (GFR) calculated according to CKD-EPI creatinine formula =60 (ml/minute/1.73 m2) (10) Participants who have participated in clinical trials of other drugs or therapeutic devices within 30 days prior to enrollment in this study (11) Systemic immunosuppressive therapy or immunomodulatory agents were used within 30 days prior to treatment in this study, or users could not be avoided during the clinical trial (12) Participants who were able to conceive and were unable to use contraception while taking the study medication (approximately 48 weeks) and for 8 weeks after the study ended Any condition that the investigator believes may compromise the safety of the subject and affect adherence to the

Design outcomes

Primary

MeasureTime frame
tetrapolipidemia;

Secondary

MeasureTime frame
HIV RNA <50 copies/ml ;CD4+, CD4+/CD8+;

Countries

China

Contacts

Public ContactYanfen Liu

Nanning Fourth People's Hospital

liuyanfenwang@126.com+86 771 553 3562

Outcome results

None listed

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