Korean Post-marketing Surveillance for Reyataz®

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

601 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2016-03-31

Brief Summary

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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

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Detailed Description

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Conditions

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HIV-1

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No Intervention

Intervention Type DRUG

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

Interventions

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No Intervention

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

Intervention Type DRUG

Eligibility Criteria

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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