A Post Marketing Survey Study to Evaluate the Safety and Effectiveness of Prezista

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Acquired Immune Deficiency Syndrome

Treatments: Drug: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT01741831

CR100805

DRV-C-11-KR-001-V06 (Other Identifier)

TMC114HIV4074 (Other Identifier)

Prezista PMS (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the safety data of darunavir in a natural clinical practice.

Full description

This is a non-interventional (a scientific study to make a clear and easy understanding of the cause and effect relationship), prospective (in which the participants are first identified and then followed forward as time passes), consecutive survey for collecting safety and efficacy data of darunavir in treatment of Acquired Immune Deficiency Syndrome (AIDS) in a natural clinical practice.

Enrollment: 225 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who are prescribed with darunavir for treatment of Acquired Immune Deficiency Syndrome (AIDS)

Exclusion criteria

• Known hypersensitivity to Prezista
• Prezista coadministered with medicinal products that are highly dependent on CYP3A for clearance

Trial design

225 participants in 1 patient group

Darunavir

Description:

Patients having Acquired Immune Deficiency Syndrome (AIDS) will be taking darunavir as per recommended doses.

Treatment:

Drug: No intervention