ZIAGEN® Post-marketing Surveillance

• Status: Completed
• Trial end date: 2015-02-05
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ViiV Healthcare
• Collaborator: GlaxoSmithKline
• Treatments: Abacavir

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