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Korean Post-marketing Surveillance for Reyataz®

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV-1

Intervention: No Intervention (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Overall contact:
For site information please email :, Email: Clinical.Trials@bms.com

Summary

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

Clinical Details

Official title: Korean Post-marketing Surveillance for Reyataz

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Adverse events occurrence

Secondary outcome:

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

CD 4 T-cell count before and after drug administration

Overall efficacy evaluation by investigator's discretion

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

For site information please email :, Email: Clinical.Trials@bms.com

Local Institution, Daegu 700-712, Korea, Republic of; Not yet recruiting
Site 011

Local Institution, Daegu 700-721, Korea, Republic of; Recruiting
Site 008

Local Institution, Daejeon 301-721, Korea, Republic of; Not yet recruiting
Site 005

Local Institution, Incheon 400-711, Korea, Republic of; Not yet recruiting
Site 018

Local Institution, Seoul 135-740, Korea, Republic of; Not yet recruiting
Site 013

Local Institution, Seoul 134-701, Korea, Republic of; Not yet recruiting
Site 007

Local Institution, Seoul 136-705, Korea, Republic of; Withdrawn

Local Institution, Seoul 140-743, Korea, Republic of; Not yet recruiting
Site 002

Local Institution, Seoul 150-950, Korea, Republic of; Not yet recruiting
Site 017

Local Institution, Seoul 152-703, Korea, Republic of; Not yet recruiting
Site 001

Local Institution, Seoul 156-755, Korea, Republic of; Not yet recruiting
Site 015

Local Institution, Seoul 120-752, Korea, Republic of; Not yet recruiting
Site 004

Local Institution, Ulsan 682-714, Korea, Republic of; Not yet recruiting
Site 006

Local Institution, Wonju, Gangwon-do 220-701, Korea, Republic of; Not yet recruiting
Site 021

Local Institution, Ansan, Gyeonggi-do 425-707, Korea, Republic of; Not yet recruiting
Site 014

Local Institution, Bucheon-Si, Gyeonggi-do 420-767, Korea, Republic of; Not yet recruiting
Site 016

Local Institution, Suwon, Gyeonggi-do 443-721, Korea, Republic of; Not yet recruiting
Site 003

Local Institution, Jeju, Jeju-do 690-767, Korea, Republic of; Not yet recruiting
Site 009

Local Institution, Chonju, Jeollabuk-do 561-712, Korea, Republic of; Not yet recruiting
Site 010

Local Institution, Iksan, Jeollabuk-do 570-711, Korea, Republic of; Not yet recruiting
Site 020

Local Institution, Jeonju-Si, Jeollabuk-do 560-750, Korea, Republic of; Terminated

Additional Information

BMS Clinical Trials Disclosure

Investigator Inquiry form

FDA Safety Alerts and Recalls

Starting date: February 2012
Last updated: August 11, 2015

Page last updated: August 23, 2015

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