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Completed

NCT Number: NCT01205243

ZIAGEN® Post-marketing Surveillance

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.

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Key information

Conditions

Infection, Human Immunodeficiency Virus I Infections

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Incheon, 400-711, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ZIAGEN®

Drug

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.

Primary outcomes

  1. Occurrence of adverse event after ZIAGEN® administration

    Time frame: 12month

Secondary outcomes

  1. Occurrence of serious adverse event after ZIAGEN® administration

    Time frame: 12month

  2. efficacy after ZIAGEN® administration

    Time frame: 12month

  3. Occurrence of unexpected adverse drug reaction after ZIAGEN® administration

    Time frame: 12 month

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Sep 20, 2010
Registry last updated
Jun 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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