Infection, Human Immunodeficiency Virus INCT01205243
ZIAGEN® Post-marketing Surveillance
An observational study of Infection, Human Immunodeficiency Virus I, run by ViiV Healthcare at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infection, Human Immunodeficiency Virus I
- What is being tested?
- ZIAGEN®
- How many people
- 671 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2010to 5 Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients administrated ZIAGEN® at the site
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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- ZIAGEN®
- Keywords
- Abacavir, post-marketing surveillance
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZIAGEN®Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| ZIAGEN® | Patients administrated ZIAGEN® at the site Receives: Drug: ZIAGEN® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse event after ZIAGEN® administration
Measured: 12month
Secondary outcomes (3)
Occurrence of serious adverse event after ZIAGEN® administration
Measured: 12month
efficacy after ZIAGEN® administration
Measured: 12month
Occurrence of unexpected adverse drug reaction after ZIAGEN® administration
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2010 (estimated)
- Study start1 Nov 2010
- Primary completion1 Feb 2015
- Study completion5 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Human Immunodeficiency Virus IStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 671 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205243
- Sponsor's protocol ID
- 114382
- Status last verified
- Jun 2018
- First submitted
- 17 Sep 2010
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01205243
- Acronym / sponsor ID
- 114382
- Keywords
- Abacavir, post-marketing surveillance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 671 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 1 Nov 2010
- Primary completion
- 1 Feb 2015 (actual)
- Study completion
- 5 Feb 2015 (actual)
- First posted
- 20 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ZIAGEN® | – | Drug: ZIAGEN®Patients administrated ZIAGEN® at the site |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients administrated ZIAGEN® at the site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | ZIAGEN® |
Primary outcome
Occurrence of adverse event after ZIAGEN® administration
Time frame: 12month
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
ViiV Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, Human Immunodeficiency Virus I, run by ViiV Healthcare at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of adverse event after ZIAGEN® administration (time frame: 12month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018.