Korean Post-marketing Surveillance for Reyataz®

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01450605
First received: October 10, 2011
Last updated: April 20, 2016
Last verified: April 2016
  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


Enrollment: 601
Study Start Date: December 2011
Study Completion Date: March 2016
Primary Completion Date: March 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

Ages Eligible for Study:   Child, Adult, Senior
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

Locations
Korea, Republic of
Local Institution
Seoul, Korea, Republic of, 110-756
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
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: April 20, 2016
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 22, 2016