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

This study is currently recruiting participants.

Verified May 2013 by Janssen Korea, Ltd., Korea

Sponsor:

Information provided by (Responsible Party):

Janssen Korea, Ltd., Korea

ClinicalTrials.gov Identifier:

NCT01741831

First received: December 3, 2012

Last updated: May 6, 2013

Last verified: May 2013

History of Changes

Purpose

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

Condition	Intervention	Phase
Acquired Immune Deficiency Syndrome	Drug: No intervention	Phase 4

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Regulatory Post Marketing Surveillance of Prezista 400mg Tablet

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Darunavir Darunavir ethanolate

U.S. FDA Resources

Further study details as provided by Janssen Korea, Ltd., Korea:

Primary Outcome Measures:

Number of patients with adverse events [ Time Frame: Up to 30 days from end of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Number of patients with viral load [ Time Frame: Screening, Week 12, Week 24 ] [ Designated as safety issue: No ]
Number of patients with CD4 T-cell count [ Time Frame: Screening, Week 12, Week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment:	3000
Study Start Date:	July 2012
Estimated Study Completion Date:	October 2016
Estimated Primary Completion Date:	October 2016 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Darunavir Patients having Acquired Immune Deficiency Syndrome (AIDS) will be taking darunavir as per recommended doses.	Drug: No intervention 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 Name: Prezista

Groups/Cohorts

Assigned Interventions

Darunavir

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

Drug: No intervention

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 Name: Prezista

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The study population will include patients who are diagnosed with Acquired Immune Deficiency Syndrome (AIDS), and who are prescribed with darunavir for treatment of AIDS.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01741831

Contacts

Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:

JNJ.CT@sylogent.com

Locations

Korea, Republic of
	Recruiting
Dae-Gu, Korea, Republic of

Sponsors and Collaborators

Janssen Korea, Ltd., Korea

Investigators

Study Director:

Janssen Korea, Ltd., Korea Clinical Trial

Janssen Korea, Ltd., Korea

More Information

Additional Information:

To learn how to participate in this trial please click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:	NCT01741831 History of Changes
Other Study ID Numbers:	CR100805, TMC114HIV4074, Prezista PMS, DRV-C-11-KR-001-V06
Study First Received:	December 3, 2012
Last Updated:	May 6, 2013
Health Authority:	Korea: Food and Drug Administration Republic of Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:

Acquired Immune Deficiency Syndrome
AIDS
TMC114
Darunavir
Prezista

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

Darunavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013

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