Korean Post-marketing Surveillance for Reyataz®

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01450605
First received: October 10, 2011
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention
HIV-1
Drug: No Intervention

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Korean Post-marketing Surveillance for Reyataz®

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Adverse events occurrence [ Time Frame: 30 days after last dose of study drug ] [ Designated as safety issue: Yes ]
    Incidence (per person-time) and confidence interval of overall adverse events and each adverse event will be computed per surveillance period


Secondary Outcome Measures:
  • Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) level before and after drug administration [ Time Frame: Baseline and 16 weeks after first treatment ] [ Designated as safety issue: No ]
  • CD 4 T-cell count before and after drug administration [ Time Frame: Baseline and 16 weeks after first treatment ] [ Designated as safety issue: No ]
  • Overall efficacy evaluation by investigator's discretion [ Time Frame: Baseline and 16 weeks after first treatment ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 600
Study Start Date: February 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients ≥ 13 years of age with HIV-1
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
Drug: No Intervention
Patients are previously on Reyataz® treatment or initiated Reyataz® for the first time

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450605

Contacts
Contact: For site information please email : Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial site that are recruiting have contact information at this time

Locations
Korea, Republic of
Local Institution Not yet recruiting
Wonju, Gangwon-do, Korea, Republic of, 220-701
Contact: , Site 021         
Local Institution Not yet recruiting
Ansan, Gyeonggi-do, Korea, Republic of, 425-707
Contact: , Site 014         
Local Institution Not yet recruiting
Bucheon-Si, Gyeonggi-do, Korea, Republic of, 420-767
Contact: , Site 016         
Local Institution Not yet recruiting
Suwon, Gyeonggi-do, Korea, Republic of, 443-721
Contact: , Site 003         
Local Institution Not yet recruiting
Jeju, Jeju-do, Korea, Republic of, 690-767
Contact: , Site 009         
Local Institution Not yet recruiting
Chonju, Jeollabuk-do, Korea, Republic of, 561-712
Contact: , Site 010         
Local Institution Not yet recruiting
Iksan, Jeollabuk-do, Korea, Republic of, 570-711
Contact: , Site 020         
Local Institution Terminated
Jeonju-Si, Jeollabuk-do, Korea, Republic of, 560-750
Local Institution Not yet recruiting
Daegu, Korea, Republic of, 700-712
Contact: , Site 011         
Local Institution Recruiting
Daegu, Korea, Republic of, 700-721
Contact: , Site 008         
Local Institution Not yet recruiting
Daejeon, Korea, Republic of, 301-721
Contact: , Site 005         
Local Institution Not yet recruiting
Incheon, Korea, Republic of, 400-711
Contact: , Site 018         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 120-752
Contact: , Site 004         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 152-703
Contact: , Site 001         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 134-701
Contact: , Site 007         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 135-740
Contact: , Site 013         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 156-755
Contact: , Site 015         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 150-950
Contact: , Site 017         
Local Institution Withdrawn
Seoul, Korea, Republic of, 136-705
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 140-743
Contact: , Site 002         
Local Institution Not yet recruiting
Ulsan, Korea, Republic of, 682-714
Contact: , Site 006         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01450605     History of Changes
Other Study ID Numbers: AI424-414
Study First Received: October 10, 2011
Last Updated: September 24, 2014
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on September 30, 2014