Korean Post-marketing Surveillance for Reyataz®

This study is currently recruiting participants. (see Contacts and Locations)
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

October 10, 2011
May 21, 2013
February 2012
December 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01450605 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Korean Post-marketing Surveillance for Reyataz®
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

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

HIV-1
Drug: No Intervention
Patients are previously on Reyataz® treatment or initiated Reyataz® for the first time
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
Intervention: Drug: No Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
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
Korea, Republic of
 
NCT01450605
AI424-414
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP