Korean Post-marketing Surveillance for Reyataz®
Overview
- Phase
- Not Applicable
- Intervention
- No Intervention
- Conditions
- HIV-1
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 601
- Locations
- 1
- Primary Endpoint
- Adverse events occurrence
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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
Investigators
Eligibility 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
Arms & 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
Intervention: No Intervention
Outcomes
Primary Outcomes
Adverse events occurrence
Time Frame: 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 Outcomes
- Overall efficacy evaluation by investigator's discretion(Baseline and 16 weeks after first treatment)
- 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)