ZIAGEN® Post-marketing Surveillance

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01205243

Enrollment

671

Registered

2010-09-20

Start date

2010-11-01

Completion date

2015-02-05

Last updated

2018-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Human Immunodeficiency Virus I

Keywords

Abacavir, post-marketing surveillance

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.

Interventions

DRUGZIAGEN®

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.

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion 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

Design outcomes

Primary

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

Secondary

Measure	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	12 month

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026