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ZIAGEN® Post-marketing Surveillance

This study is currently recruiting participants.
Verified June 2011 by ViiV Healthcare
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01205243
First received: September 17, 2010
Last updated: June 23, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention
Infection, Human Immunodeficiency Virus I
 Drug: ZIAGEN®

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • Occurrence of adverse event after ZIAGEN® administration [ Time Frame: 6month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Occurrence of unexpected or serious adverse event after ZIAGEN® administration [ Time Frame: 6month ] [ Designated as safety issue: Yes ]
  • efficacy after ZIAGEN® administration [ Time Frame: 6month ] [ Designated as safety issue: No ]

Estimated Enrollment: 780
Study Start Date: November 2010
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ZIAGEN®
Patients administrated ZIAGEN® at the site
 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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients administrated ZIAGEN® at the site

Criteria

Inclusion Criteria:

  • Subjects administered with ZIAGEN® in combination with other antiretroviral agents for the treatment of HIV infection
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol and follow the administration regimen
  • Subjects administered with ZIAGEN® following the locally approved prescribing information

Exclusion Criteria:

  • Subjects with hypersensitivity to ZIAGEN® or ingredients
  • Subjects with moderate or severe hepatic impairment
  • Subject with end-stage renal disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01205243

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
Korea, Republic of
GSK Investigational Site Recruiting
Incheon, Korea, Republic of, 400-711
Contact: US GSK Clinical Trials Call Center     877-379-3718     GSKClinicalSupportHD@gsk.com    
Contact: EU GSK Clinical Trials Call Center     +44 (0) 20 8990 4466     GSKClinicalSupportHD@gsk.com    
Sponsors and Collaborators
ViiV Healthcare
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials ViiV Healthcare
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01205243     History of Changes
Other Study ID Numbers: 114382
Study First Received: September 17, 2010
Last Updated: June 23, 2011
Health Authority: Korea: Korea Food & Drug Administration

Keywords provided by ViiV Healthcare:
Abacavir
post-marketing surveillance

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

ClinicalTrials.gov processed this record on May 22, 2013