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
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Condition or disease | Intervention/treatment |
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Infection, Human Immunodeficiency Virus I | Drug: ZIAGEN® |
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 |
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 |
Group/Cohort | Intervention/treatment |
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ZIAGEN®
Patients administrated ZIAGEN® at the site
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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.
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- Occurrence of adverse event after ZIAGEN® administration [ Time Frame: 12month ]
- Occurrence of serious adverse event after ZIAGEN® administration [ Time Frame: 12month ]
- efficacy after ZIAGEN® administration [ Time Frame: 12month ]
- Occurrence of unexpected adverse drug reaction after ZIAGEN® administration [ Time Frame: 12 month ]

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

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