Korean Post-marketing Surveillance for Reyataz®

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: HIV-1

Treatments: Drug: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT01450605

AI424-414

Details and patient eligibility

About

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

Enrollment: 601 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

601 participants in 1 patient group

Patients ≥ 13 years of age with HIV-1

Description:

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

Treatment:

Drug: No Intervention