Human Immunodeficiency VirusNCT01638312
Development of Method of Fructose Identification in Urine to Detect the Viral Infection
An observational study of Human Immunodeficiency Virus, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2011to May 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: the person who has HIV infection
Who may be able to join
- HIV infection
Who cannot join
- who are in highly active antiretroviral therapy(HARRT) therapy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Tropical Medicine Center, Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, 807
About this study
Official title: The Development of Fast and Simple Method of Fructose Identification in Urine to Detect the Viral Infection in Early Stage
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.
Read the detailed description
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.
- Conditions
- Human Immunodeficiency Virus
- Keywords
- HIV, fructose
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV infection patient and health people | The study does not have intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (-)
Measured: Participants provided urine samples once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startJun 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JihJin Tsai, MD, Principal investigator, The Medicines Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638312
- Sponsor's protocol ID
- KMUH-IRB-20110188
- Status last verified
- Sep 2012
- First submitted
- 20 Jan 2012
- Last updated
- 5 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of Fast and Simple Method of Fructose Identification in Urine to Detect the Viral Infection in Early Stage
- ClinicalTrials.gov ID
- NCT01638312
- Acronym / sponsor ID
- KMUH-IRB-20110188
- Conditions
- Human Immunodeficiency Virus
- Keywords
- HIV, fructose
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 11 Jul 2012 (estimated)
- Results
- Posted 5 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV infection patient and health people | – | –The study does not have intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- the person who has HIV infection
Key inclusion criteria (1 listed)
- HIV infection
Key exclusion criteria (1 listed)
- who are in highly active antiretroviral therapy(HARRT) therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fructose Identification in Urine to Detect the Viral Infection : Number of Participants With Positive and Negative Waveform
Time frame: Participants provided urine samples once
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 (-)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Human Immunodeficiency Virus
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JihJin Tsai, MD principal investigator
The Medicines Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fructose Identification in Urine to Detect the Viral Infection : Number of Participants With Positive and Negative Waveform (time frame: Participants provided urine samples once). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2015.