ZIAGEN® Post-marketing Surveillance

Completed

• Conditions: Infection, Human Immunodeficiency Virus I
• Interventions: Drug: ZIAGEN®

• Registration Number: NCT01205243
• Lead Sponsor: ViiV Healthcare

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.

Study Timeline

• Study First Submitted: 2010-09-17
• Study First Submitted QC: 2010-09-17
• Study First Posted: 2010-09-20
• Study Start: 2010-11-01
• Primary Completion: 2015-02-01
• Study Completion: 2015-02-05
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 671

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ZIAGEN®	ZIAGEN®	Patients administrated ZIAGEN® at the site

Primary Outcome Measures

Name	Time	Method
Occurrence of adverse event after ZIAGEN® administration	12month

Secondary Outcome Measures

Name	Time	Method
Occurrence of unexpected adverse drug reaction after ZIAGEN® administration	12 month
Occurrence of serious adverse event after ZIAGEN® administration	12month
efficacy after ZIAGEN® administration	12month

Trial Locations

Locations (1)

GSK Investigational Site; 🇰🇷 Incheon, Korea, Republic of