Clinical Epidemiology Cohort Study for Patient Living Wit... | NCT04061889

Studies
Clinical Epidemiology Cohort Study for Patient Living With HIV

NCT04061889

Sponsor

Kaohsiung Veterans General Hospital.

Status

Unknown status

Last Update Posted

Aug 20, 2019Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

HIV-1 Infection

Interventions

intervention name is not applicable

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2019Actual

Primary Completion Date

Mar 31, 2022Estimated

Completion Date

Mar 31, 2022Estimated

First Submitted Date

Aug 15, 2019

First Submission Date that Met QC Criteria

Aug 17, 2019

First Posted Date

Aug 20, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2019

Last Update Posted Date

Aug 20, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hung Chin Tsai, Visiting Physician, Kaohsiung Veterans General Hospital.Principal Investigator

Lead Sponsor

Kaohsiung Veterans General Hospital.OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a retrospective observational cohort study for the patient living with HIV aiming to understand more in disease progress, resistant mutation, comorbidity, and common coinfection.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intervention name is not applicable	Other	Another intervention is not applicable either, due to the observational study design

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hazard ratio of cohort epidemiology characteristics in treatment failure, renal failure and hepatitis D coinfection		on average of 3 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient living with HIV receiving follow-up in Kaohsiung VGH

Exclusion Criteria:

not applicable

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

HIV-1 infected adult

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hung Chin Tsai, MD, PhD	Contact	+886-7-3468299		Hctsai1011@yahoo.com.tw
Che Chan Chou	Contact	+886-7-3468299

Overall Officials

Name	Affiliation	Role
Hung Chin Tsai, MD,PhD	Kaohsiung Veteran General Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaohsiung Veteran General Hospital	Recruiting	Kaohsiung City	Kaohsiung City		Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided