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

October 1, 2014 updated by: National Center for Global Health and Medicine, Japan

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-

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

1800

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Vietnamese HIV-infected patients who are registered in the NHTD (National Hospital of Tropical Diseases) -ACC (AIDS Clinical Center, NCGM) cohort.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Global Health and Medicine, Japan

Investigators

  • Principal Investigator: Shinichi Oka, MD. PhD, National Center for Global Health and Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

October 1, 2014

First Submitted That Met QC Criteria

October 1, 2014

First Posted (Estimate)

October 3, 2014

Study Record Updates

Last Update Posted (Estimate)

October 3, 2014

Last Update Submitted That Met QC Criteria

October 1, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCGM-G-001074-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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