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

Sponsor
National Center for Global Health and Medicine, Japan (Other)
Overall Status
Unknown status
CT.gov ID
NCT02256579
Collaborator
(none)
1,800
Enrollment
29
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1800 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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-
    Study Start Date :
    Oct 1, 2014
    Anticipated Primary Completion Date :
    Nov 1, 2016
    Anticipated Study Completion Date :
    Mar 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • National Center for Global Health and Medicine, Japan

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Center for Global Health and Medicine, Japan
    ClinicalTrials.gov Identifier:
    NCT02256579
    Other Study ID Numbers:
    • NCGM-G-001074-01
    First Posted:
    Oct 3, 2014
    Last Update Posted:
    Oct 3, 2014
    Last Verified:
    Apr 1, 2014
    Keywords provided by National Center for Global Health and Medicine, Japan
    TDF:Tenofovir, Urine beta2microglobulin
    Additional relevant MeSH terms:
    Infections
    Renal Insufficiency
    Disease

    Study Results

    No Results Posted as of Oct 3, 2014