Korean Post-marketing Surveillance for Reyataz®

HIV-1 Clinical Trial

Official title:

Korean Post-marketing Surveillance for Reyataz®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01450605
• Other study ID #: AI424-414
• Status: Completed
• Phase: N/A
• First received: October 10, 2011
• Last updated: April 20, 2016
• Start date: December 2011
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 601
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV-1

Intervention

Drug:
• No Intervention
Patients are previously on Reyataz® treatment or initiated Reyataz® for the first time

Locations

Country	Name	City	State
Korea, Republic of	Local Institution	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events occurrence	Incidence (per person-time) and confidence interval of overall adverse events and each adverse event will be computed per surveillance period	30 days after last dose of study drug	Yes
Secondary	Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) level before and after drug administration		Baseline and 16 weeks after first treatment	No
Secondary	CD 4 T-cell count before and after drug administration		Baseline and 16 weeks after first treatment	No
Secondary	Overall efficacy evaluation by investigator's discretion	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	Baseline and 16 weeks after first treatment	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form