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NCT02256579 Clinical Trial

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

HIV Infection Clinical Trial

Official title:
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-

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02256579
Other study ID # NCGM-G-001074-01
Secondary ID
Status Enrolling by invitation
Phase N/A
First received October 1, 2014
Last updated October 1, 2014
Start date October 2014
Est. completion date March 2017

Study information
Verified date April 2014
Source National Center for Global Health and Medicine, Japan
Contact n/a
Is FDA regulated No
Health authority Japan: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 1800
Est. completion date March 2017
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
National Center for Global Health and Medicine, Japan

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of urinary beta2microglobulin, urinary protein and serum creatinine among Vietnamese HIV-infected patients Follow up Vietnamese HIV-infected patients, for their renal function including urinary beta2microglobulin, urinary protein and serum creatinine for 3 years 3 years No
Secondary Evaluation of risk factors for renal dysfunction and tubular dysfunction 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.		 3 years No
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