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Completed

NCT Number: NCT01741831

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

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

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Key information

Conditions

Acquired Immune Deficiency Syndrome Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Daegu, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Drug

This is an observational study. Darunavir will be administered as per the recommended doses and will be given orally for a period of 24 weeks. For treatment naive (never received treatment for AIDS) patients: Darunavir 800 mg will be adminstered along with ritonavir 100 mg once daily. For experienced patients: Darunavir 600 mg will be administered along with ritonavir 100 mg twice daily.

Other names: Prezista

Primary outcomes

  1. Number of patients with adverse events

    Time frame: Up to 30 days from end of treatment

Secondary outcomes

  1. Number of patients with viral load

    Time frame: Screening, Week 12, Week 24

  2. Number of patients with CD4 T-cell count

    Time frame: Screening, Week 12, Week 24

Sponsors and collaborators

Lead sponsor

Janssen Korea, Ltd., Korea

Industry

Registry information

Official study title

Regulatory Post Marketing Surveillance of Prezista 400mg Tablet

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Dec 5, 2012
Registry last updated
Dec 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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