Korean Post-marketing Surveillance for Reyataz®

This study is currently recruiting participants.
Verified May 2013 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01450605
First received: October 10, 2011
Last updated: May 21, 2013
Last verified: May 2013
  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: December 2015
Estimated Primary Completion Date: December 2015 (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
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, 140-743
Contact: , Site 002         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 152-703
Contact: , Site 001         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 120-752
Contact: , Site 004         
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
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: May 21, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Atazanavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014