ZIAGEN® Post-marketing Surveillance

June 18, 2018 updated by: ViiV Healthcare

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

671

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients administrated ZIAGEN® at the site

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of adverse event after ZIAGEN® administration
Time Frame: 12month
12month

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of serious adverse event after ZIAGEN® administration
Time Frame: 12month
12month
efficacy after ZIAGEN® administration
Time Frame: 12month
12month
Occurrence of unexpected adverse drug reaction after ZIAGEN® administration
Time Frame: 12 month
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ViiV Healthcare

Collaborators

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

February 5, 2015

Study Registration Dates

First Submitted

September 17, 2010

First Submitted That Met QC Criteria

September 17, 2010

First Posted (ESTIMATE)

September 20, 2010

Study Record Updates

Last Update Posted (ACTUAL)

June 19, 2018

Last Update Submitted That Met QC Criteria

June 18, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114382

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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