ZIAGEN® Post-marketing Surveillance

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 1, 2015

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

  • 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.

Arms, Groups and Cohorts

  • ZIAGEN®
    • Patients administrated ZIAGEN® at the site

Clinical Trial Outcome Measures

Primary Measures

  • Occurrence of adverse event after ZIAGEN® administration
    • Time Frame: 12month

Secondary Measures

  • Occurrence of serious adverse event after ZIAGEN® administration
    • Time Frame: 12month
  • efficacy after ZIAGEN® administration
    • Time Frame: 12month
  • Occurrence of unexpected adverse drug reaction after ZIAGEN® administration
    • Time Frame: 12 month

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ViiV Healthcare
  • Collaborator
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • GSK Clinical Trials, Study Director, ViiV Healthcare

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