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

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-

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02256579

Enrollment

1800

Registered

2014-10-03

Start date

2014-10-31

Completion date

2017-03-31

Last updated

2014-10-03

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

Conditions

HIV Infection, Renal Function Disorder, Renal Tubular Disorder

Keywords

TDF:Tenofovir, Urine beta2microglobulin

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Outcome results