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ZIAGEN® Post-marketing Surveillance

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01205243

First Posted: September 20, 2010

Last Update Posted: September 23, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

GlaxoSmithKline

Information provided by (Responsible Party):

ViiV Healthcare

Purpose

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.

Condition	Intervention
Infection, Human Immunodeficiency Virus I	Drug: ZIAGEN®


Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Abacavir Abacavir sulfate

U.S. FDA Resources

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:

Occurrence of adverse event after ZIAGEN® administration [ Time Frame: 12month ]

Secondary Outcome Measures:

Occurrence of serious adverse event after ZIAGEN® administration [ Time Frame: 12month ]
efficacy after ZIAGEN® administration [ Time Frame: 12month ]
Occurrence of unexpected adverse drug reaction after ZIAGEN® administration [ Time Frame: 12 month ]


Enrollment:	671
Study Start Date:	November 2010
Study Completion Date:	February 2015
Primary Completion Date:	February 2015 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
ZIAGEN® Patients administrated ZIAGEN® at the site	Drug: ZIAGEN® 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.

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients administrated ZIAGEN® at the site

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01205243

Locations


Korea, Republic of
GSK Investigational Site
Incheon, Korea, Republic of, 400-711

Sponsors and Collaborators

ViiV Healthcare

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	ViiV Healthcare

More Information


Responsible Party:	ViiV Healthcare
ClinicalTrials.gov Identifier:	NCT01205243 History of Changes
Other Study ID Numbers:	114382
First Submitted:	September 17, 2010
First Posted:	September 20, 2010
Last Update Posted:	September 23, 2015
Last Verified:	September 2015

Keywords provided by ViiV Healthcare:


Abacavir post-marketing surveillance

Additional relevant MeSH terms:


Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases	Slow Virus Diseases Abacavir Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents

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