NCT01638312

Brief Summary

The goal of this research is the attempt to implement a new research method based on modern electrochemistry successes, in particular the development of the polarographic method of fructose and fructose diphosphate identification and its implementation to detect the viral infection in early stage. There will be 20 samples from the HIV-infected patients and 30 samples from the heath controls. The study will collect 10ml urine and examined fructose and fructose-diphosphate using the polarographic method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2012

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

October 5, 2015

Completed
Last Updated

October 5, 2015

Status Verified

September 1, 2012

Enrollment Period

1.9 years

First QC Date

January 20, 2012

Results QC Date

February 10, 2015

Last Update Submit

September 3, 2015

Conditions

Keywords

HIV, fructose

Outcome Measures

Primary Outcomes (1)

  • Fructose Identification in Urine to Detect the Viral Infection : Number of Participants With Positive and Negative Waveform

    This detection technique, after a viral infection caused by the use of cell pathological changes and urine metabolic waste - fructose concentration, derivatives.Health News voltage changes to detect viral pathogens of activity and virulence. Because viral infection caused by the voltage change has its typical, So you can use voltage measurements to calibrate the presence and activity of a viral infection. 1.How to interpretation the data The gap between values on X-axis is σ, and 50 is a reference to the center position. For example, the sample maybe contain with HIV virus if σ≧10 units. σ≧10 abnormal positive (+) σ\<10 normal negative (-)

    Participants provided urine samples once

Study Arms (1)

HIV infection patient and health people

The study does not have intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

the person who has HIV infection

You may qualify if:

  • HIV infection

You may not qualify if:

  • who are in highly active antiretroviral therapy(HARRT) therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tropical Medicine Center, Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan, 807, Taiwan

Location

Biospecimen

Retention: NONE RETAINED

urine

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
JihJin Tsai, MD
Organization
Kaohsiung Medical University Chung-Ho Memorial Hospital

Study Officials

  • JihJin Tsai, MD

    The Medicines Company

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2012

First Posted

July 11, 2012

Study Start

June 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

October 5, 2015

Results First Posted

October 5, 2015

Record last verified: 2012-09

Locations