NCT02256579

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

October 3, 2014

Status Verified

April 1, 2014

Enrollment Period

2.1 years

First QC Date

October 1, 2014

Last Update Submit

October 1, 2014

Conditions

HIV InfectionRenal Function DisorderRenal Tubular Disorder

Keywords

TDF:Tenofovir, Urine beta2microglobulin

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Evaluation of risk factors for renal dysfunction and tubular dysfunction

    3 years

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • HIV-infected patients in the NHTD -ACC cohort who are under cART or will start cART and can provide written informed consents.

You may not qualify if:

  • HIV-infected patients who drop out of treatment within 6 months from the entry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Complete blood cell count, CD4+ cell count, AST, ALT, Serum-creatinine, HIV-1 plasma viral loads, HBs antigen, anti-HBc antibody, anti-HBs antibody, anti-HCV antibody, Urine-protein, Urine-creatinine and urine beta2microglobulin.

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Shinichi Oka, MD. PhD

    National Center for Global Health and Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2014

First Posted

October 3, 2014

Study Start

October 1, 2014

Primary Completion

November 1, 2016

Study Completion

March 1, 2017

Last Updated

October 3, 2014

Record last verified: 2014-04