ZIAGEN® Post-marketing Surveillance

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by ViiV Healthcare
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01205243
First received: September 17, 2010
Last updated: August 7, 2014
Last verified: June 2014

September 17, 2010
August 7, 2014
November 2010
June 2016   (final data collection date for primary outcome measure)
Occurrence of adverse event after ZIAGEN® administration [ Time Frame: 12month ] [ Designated as safety issue: No ]
Occurence of adverse event after ZIAGEN® administration [ Time Frame: 6month ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01205243 on ClinicalTrials.gov Archive Site
  • Occurrence of serious adverse event after ZIAGEN® administration [ Time Frame: 12month ] [ Designated as safety issue: No ]
  • efficacy after ZIAGEN® administration [ Time Frame: 12month ] [ Designated as safety issue: No ]
  • Occurrence of unexpected adverse drug reaction after ZIAGEN® administration [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Occurence of unexpected or serious adverse event after ZIAGEN® administration [ Time Frame: 6month ] [ Designated as safety issue: Yes ]
  • effectiveness after ZIAGEN® administration [ Time Frame: 6month ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients administrated ZIAGEN® at the site

Infection, Human Immunodeficiency Virus I
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.
ZIAGEN®
Patients administrated ZIAGEN® at the site
Intervention: Drug: ZIAGEN®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
780
June 2016
June 2016   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Korea, Republic of
 
NCT01205243
114382
No
ViiV Healthcare
ViiV Healthcare
GlaxoSmithKline
Study Director: GSK Clinical Trials ViiV Healthcare
ViiV Healthcare
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP