Korean Post-marketing Surveillance for Reyataz®

Completed

• Conditions: HIV-1
• Interventions: Drug: No Intervention

• Registration Number: NCT01450605
• Lead Sponsor: Bristol-Myers Squibb

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-10
• Study First Submitted QC: 2011-10-10
• Study First Posted: 2011-10-12
• Study Start: 2011-12
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-20
• Last Update Posted: 2016-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 601

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

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Exclusion Criteria

• According to Warning/Caution in local label

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients ≥ 13 years of age with HIV-1	No Intervention	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

Primary Outcome Measures

Name	Time	Method
Adverse events occurrence	30 days after last dose of study drug	Incidence (per person-time) and confidence interval of overall adverse events and each adverse event will be computed per surveillance period

Secondary Outcome Measures

Name	Time	Method
Overall efficacy evaluation by investigator's discretion	Baseline and 16 weeks after first treatment	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
Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) level before and after drug administration	Baseline and 16 weeks after first treatment
CD 4 T-cell count before and after drug administration	Baseline and 16 weeks after first treatment

Trial Locations

Locations (1)

Local Institution; 🇰🇷 Seoul, Korea, Republic of