Korean Post-marketing Surveillance for Reyataz®

The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Reyataz® so that the regulatory authority can manage the marketing approval properly

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Key information

Conditions

HIV-1

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Seoul, 110-756, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients ≥ 13 years of age with HIV-1 who are on Reyataz® treatment at the time of enrollment and have never been participated in this study previously or who are initiating Reyataz® treatment for the first time in the real-life conditions in its registered indication(s) as required by KFDA

Exclusion criteria

According to Warning/Caution in local label

Treatment and study plan

No intervention

Drug

Patients are previously on Reyataz® treatment or initiated Reyataz® for the first time

Primary outcomes

Adverse events occurrence

Time frame: 30 days after last dose of study drug

Incidence (per person-time) and confidence interval of overall adverse events and each adverse event will be computed per surveillance period

Secondary outcomes

Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) level before and after drug administration

Time frame: Baseline and 16 weeks after first treatment
CD 4 T-cell count before and after drug administration

Time frame: Baseline and 16 weeks after first treatment
Overall efficacy evaluation by investigator's discretion

Time frame: Baseline and 16 weeks after first treatment

Based on laboratory test results including HIV RNA (viral load) and CD4 T-cell count, clinical findings, subjective findings and objective findings in comparison to baseline

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start: 2011
Primary completion: 2016
Study completion: 2016
First posted: Oct 12, 2011
Registry last updated: Apr 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed