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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01205243
Other study ID # 114382
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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