ZIAGEN® Post-marketing Surveillance
This study is currently recruiting participants.
(see Contacts and Locations)
Verified June 2014 by ViiV Healthcare
Sponsor:
ViiV Healthcare
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
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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 ]
| 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
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
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: | ViiV Healthcare |
| ClinicalTrials.gov Identifier: | NCT01205243 History of Changes |
| Other Study ID Numbers: | 114382 |
| Study First Received: | September 17, 2010 |
| Last Updated: | August 7, 2014 |
| 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 Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections RNA Virus Infections |
Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Virus Diseases |
ClinicalTrials.gov processed this record on March 03, 2015