ZIAGEN® Post-marketing Surveillance

N/ACompletedNCT01205243

ViiV Healthcare671 enrolled

Overview

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.

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

671

Conditions

Infection, Human Immunodeficiency Virus I

Interventions

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

GSK Investigational Site

Incheon, South Korea

Outcomes

Primary Outcomes

Occurrence of adverse event after ZIAGEN® administration

Time frame: 12month

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

Data from ClinicalTrials.gov

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