ZIAGEN® Post-marketing Surveillance

Infection, Human Immunodeficiency Virus I Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01205243
• Other study ID #: 114382
• Status: Completed
• Start date: November 1, 2010
• Est. completion date: February 5, 2015

Study information

• Verified date: June 2018
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 671
• Est. completion date: February 5, 2015
• Est. primary completion date: February 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes
• Infection, Human Immunodeficiency Virus I

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	GSK Investigational Site	Incheon

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	GlaxoSmithKline

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of adverse event after ZIAGEN® administration		12month
Secondary	Occurrence of serious adverse event after ZIAGEN® administration		12month
Secondary	efficacy after ZIAGEN® administration		12month
Secondary	Occurrence of unexpected adverse drug reaction after ZIAGEN® administration		12 month