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ZIAGEN® Post-marketing Surveillance

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ClinicalTrials.gov Identifier: NCT01205243
Recruitment Status : Completed
First Posted : September 20, 2010
Last Update Posted : September 23, 2015
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Design
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Study Type : Observational
Actual Enrollment : 671 participants
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 2010
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Group/Cohort Intervention/treatment
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.


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT01205243


Locations
Korea, Republic of
GSK Investigational Site
Incheon, Korea, Republic of, 400-711
Sponsors and Collaborators
ViiV Healthcare
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials ViiV Healthcare
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01205243     History of Changes
Other Study ID Numbers: 114382
First Posted: September 20, 2010    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by ViiV Healthcare:
Abacavir
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
Abacavir
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