ZIAGEN® Post-marketing Surveillance | NCT01205243

Studies
ZIAGEN® Post-marketing Surveillance

NCT01205243

Sponsor

ViiV Healthcare

Status

Completed

Last Update Posted

Jun 19, 2018Actual

Enrollment

671Actual

Phase

Not provided

Conditions

Infection, Human Immunodeficiency Virus I

Interventions

ZIAGEN®

Countries

South Korea

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

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2010

Primary Completion Date

Feb 1, 2015Actual

Completion Date

Feb 5, 2015Actual

First Submitted Date

Sep 17, 2010

First Submission Date that Met QC Criteria

Sep 17, 2010

First Posted Date

Sep 20, 2010Estimated

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

Jun 18, 2018

Last Update Posted Date

Jun 19, 2018Actual

Name	Class
GlaxoSmithKline	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor the safety and efficacy of ZIAGEN® administered in Korean patients according to the prescribing information.

Detailed Description

This study will collect clinical data, mainly focused on safety, in Korean population as per the requirement of KFDA for market authorization.

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

671Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ZIAGEN®		Patients administrated ZIAGEN® at the site	Drug: ZIAGEN®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ZIAGEN®	Drug	Basically there is no treatment allocation. Subjects who would be administrated ZIAGEN® at their physician's discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of adverse event after ZIAGEN® administration		12month

Secondary Outcomes

Measure	Description	Time Frame
Occurrence of serious adverse event after ZIAGEN® administration		12month
efficacy after ZIAGEN® administration		12month
Occurrence of unexpected adverse drug reaction after ZIAGEN® administration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

All subjects must satisfy the following criteria.

Subject who is treated in combination with other antiretroviral agents for the treatment of HIV infection.
Subject who is considered to follow this post marketing surveillance protocol by the investigator.
Subject who is treated with ZIAGEN® according to the prescribing information. As considering the characteristic of observational post marketing surveillance, the exclusion criteria is not strict. All investigators should prescribe ZIAGEN® according to the prescribing information which approved in Korea.
Subjects with hypersensitivity to ZIAGEN® or ingredients
Subjects with moderate or severe hepatic impairment
Subject with end-stage renal disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients administrated ZIAGEN® at the site

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	ViiV Healthcare	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Incheon		400-711	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C106538	abacavir

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided