ZIAGEN® Post-marketing Surveillance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01205243
Recruitment Status : Completed
First Posted : September 20, 2010
Last Update Posted : June 19, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Infection, Human Immunodeficiency Virus I Drug: ZIAGEN®

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 Type : Observational
Actual Enrollment : 671 participants
Observational Model: Other
Time Perspective: Prospective
Official 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
Study Start Date : November 1, 2010
Actual Primary Completion Date : February 1, 2015
Actual Study Completion Date : February 5, 2015

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Patients administrated ZIAGEN® at the site
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 Outcome Measures :
  1. Occurrence of adverse event after ZIAGEN® administration [ Time Frame: 12month ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients administrated ZIAGEN® at the site

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01205243

Korea, Republic of
GSK Investigational Site
Incheon, Korea, Republic of, 400-711
Sponsors and Collaborators
ViiV Healthcare
Study Director: GSK Clinical Trials ViiV Healthcare

Responsible Party: ViiV Healthcare Identifier: NCT01205243     History of Changes
Other Study ID Numbers: 114382
First Posted: September 20, 2010    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018

Keywords provided by ViiV Healthcare:
post-marketing surveillance

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents