Korean Post-marketing Surveillance for Reyataz®
This study is currently recruiting participants.
Verified May 2013 by Bristol-Myers Squibb
Sponsor:
Bristol-Myers Squibb
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
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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 June 17, 2013