Status:
COMPLETED
ZIAGEN® Post-marketing Surveillance
Lead Sponsor:
ViiV Healthcare
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Infection, Human Immunodeficiency Virus I
Eligibility:
All Genders
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 Gl...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 5 2015
Estimated Enrollment :
671 Patients enrolled
Trial Details
Trial ID
NCT01205243
Start Date
November 1 2010
End Date
February 5 2015
Last Update
June 19 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Incheon, South Korea, 400-711