ZIAGEN® Post-marketing Surveillance
This study has been completed.
Sponsor:
ViiV Healthcare
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01205243
First received: September 17, 2010
Last updated: September 21, 2015
Last verified: September 2015
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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:
Further study details as provided by ViiV Healthcare:
Primary Outcome Measures:
- Occurrence of adverse event after ZIAGEN® administration [ Time Frame: 12month ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 671 |
| Study Start Date: | November 2010 |
| Study Completion Date: | February 2015 |
| Primary Completion Date: | February 2015 (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| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Both |
| 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01205243
Please refer to this study by its ClinicalTrials.gov identifier: 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
| Responsible Party: | ViiV Healthcare |
| ClinicalTrials.gov Identifier: | NCT01205243 History of Changes |
| Other Study ID Numbers: | 114382 |
| Study First Received: | September 17, 2010 |
| Last Updated: | September 21, 2015 |
| Health Authority: | Korea: Korea Food & Drug Administration |
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 |
ClinicalTrials.gov processed this record on September 26, 2016