Utility of Urinary beta2 Microglobulin as an Early Marker of Renal Dysfunction in Vietnamese HIV-Infected Patients

• Conditions: HIV Infection; Renal Function Disorder; Renal Tubular Disorder

• Registration Number: NCT02256579
• Lead Sponsor: National Center for Global Health and Medicine, Japan

Brief Summary

This study is to investigate clinical utility of beta2 microglobulin as an early marker for renal dysfunction caused by Tenofovir in Vietnamese HIV-infected patients.

Detailed Description

An observational study to investigate clinical utility of beta2 microglobulin as an early marker for renal dysfunction caused by Tenofovir in Vietnamese HIV-infected patients.

Study Timeline

• Status Verified: 2014-04
• Study Start: 2014-10
• Study First Submitted: 2014-10-01
• Study First Submitted QC: 2014-10-01
• Last Update Submitted: 2014-10-01
• Study First Posted: 2014-10-03
• Last Update Posted: 2014-10-03
• Primary Completion: 2016-11
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1800

Inclusion Criteria

• HIV-infected patients in the NHTD -ACC cohort who are under cART or will start cART and can provide written informed consents.

Exclusion Criteria

• HIV-infected patients who drop out of treatment within 6 months from the entry.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of urinary beta2microglobulin, urinary protein and serum creatinine among Vietnamese HIV-infected patients	3 years	Follow up Vietnamese HIV-infected patients, for their renal function including urinary beta2microglobulin, urinary protein and serum creatinine for 3 years

Secondary Outcome Measures

Name	Time	Method
Evaluation of risk factors for renal dysfunction and tubular dysfunction	3 years	Risk factors for renal and tubular dysfunction were evaluated.; Risk factors including: Age, sex, body weight, history of ART, AIDS or non-AIDS complication and concomitant use of cotrimoxazole, Hepatitis C virus antibody and Hepatitis B virus Ag antigen, CD4 positive cell count and HIV viral load.