Korean Post-marketing Surveillance for Reyataz®

NCT01450605 | Completed

• 1 other identifier: AI424-414
• Study Type: observational
• Target: 601
• Locations: 1 country
• Sites: 1

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

Conditions

HIV-1

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

• Overall efficacy evaluation by investigator's discretion

  Baseline and 16 weeks after first treatment

Study Arms (1)

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

Interventions

No Intervention DRUG

Patients are previously on Reyataz® treatment or initiated Reyataz® for the first time

Patients ≥ 13 years of age with HIV-1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• According to Warning/Caution in local label

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Seoul, 110-756, South Korea

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2011
• First Posted: October 12, 2011
• Study Start: December 1, 2011
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 21, 2016

Record last verified: 2016-04

Locations

KR (1)