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Clinical study on the effect of hemodialysis on BIC/FTC/TAF metabolism in HIV patients with end-stage renal disease

Clinical study on the effect of hemodialysis on BIC/FTC/TAF metabolism in HIV patients with end-stage renal disease

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400095059
Enrollment
Unknown
Registered
2024-12-31
Start date
2024-12-31
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Continuous Veno-venous Hemodiafiltration

Interventions

Observations:N/A

Sponsors

Public health clinical center of Chengdu
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age>=18 years; 2. Diagnosed with HIV infection and meeting the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of HIV/AIDS (2021 Edition) ; 3. Treatment with bicembrolol anti-HIV for more than 6 months, and HIV-RNA < 50 copies/ml within 6 months; 4. Patients should be in the end-stage renal disease with an estimated glomerular filtration rate (eGFR) of less than 15 mL/min/1.73 m² and stable for at least three months; 5. Hemodialysis twice a week for at least 3 months; 6.Patient or his/her legal guardian has signed informed consent, is willing to participate in the study and complies with the study protocol; 7. Patients are willing to obey medication education and take medication immediately after dialysis on the same day; 8. Patients should have good compliance and be able to cooperate in completing all examinations and follow-up visits during the study.

Exclusion criteria

Exclusion criteria: 1. Patients with comorbidities and complications that may affect drug metabolism and clearance; 2. Patients undergoing peritoneal dialysis or other non-hemodialysis treatment; 3. May use drugs that affect the concentration of the drug in the blood of biconprenol; 4.Patients who are using drugs known to be significantly toxic to the kidneys, or who need to use such drugs during the study period; 5.A history of serious cardiovascular disease, such as myocardial infarction, unstable angina pectoris or severe arrhythmia; 6.Have serious liver disease, such as cirrhosis or chronic active hepatitis, which may affect drug metabolism; 7.Patients who are allergic to the investigational drug or any of its excipients; 8.Pregnant or lactating women; 9.Patients with unstable mental state or cognitive dysfunction, unable to understand the content and requirements of the study; 10.Other situations in which the investigator deems it inappropriate to participate in the study.

Design outcomes

Primary

MeasureTime frame
drug concentration in blood;

Secondary

MeasureTime frame
HIV-RNA;CD4+T helper cell subsets;CD4/CD8 ratio;Interleukin-6 (IL-6);Serum Amyloid A(SAA);C-reactive protein(CRP);The urea clearance index(Kt/V);Urea Reduction Ratio(URR);Dialysis dose;Time interval between last medication intake and this dialysis;Adverse Drug Events and Their Incidence Rates;

Countries

China

Contacts

Public ContactLv Fei

Public health clinical center of Chengdu

1654475882@qq.com+86 133 0808 9024

Outcome results

None listed

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