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

Overview

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.

Full Title of Study: “Vietnam-Japan Cooperative Research on Prognosis of HIV-1-infection -Clinical Utility of Urinary beta2 Microglobulin as an Early Marker of Renal Dysfunction Caused by Use of Tenofovir in Vietnamese HIV-Infected Patients-“

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2016

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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Evaluation of risk factors for renal dysfunction and tubular dysfunction
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Center for Global Health and Medicine, Japan
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Shinichi Oka, MD. PhD, Principal Investigator, National Center for Global Health and Medicine

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