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

NCT01741831 | Completed

• 4 other identifiers: CR100805TMC114HIV4074Prezista PMSDRV-C-11-KR-001-V06
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acquired Immune Deficiency Syndrome

Keywords

Acquired Immune Deficiency Syndrome; AIDS; TMC114; Darunavir; Prezista

Outcome Measures

Primary Outcomes (1)

• Number of patients with adverse events

  Up to 30 days from end of treatment

Secondary Outcomes (2)

• Number of patients with viral load

  Screening, Week 12, Week 24

• Number of patients with CD4 T-cell count

  Screening, Week 12, Week 24

Study Arms (1)

Darunavir

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

Drug: No intervention

Interventions

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.

Also known as: Prezista

Darunavir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

Study Sites (1)

Unknown Facility

Daegu, South Korea

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Darunavir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janssen Korea, Ltd., Korea Clinical Trial

  Janssen Korea, Ltd., Korea

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: December 5, 2012
• Study Start: July 1, 2012
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: December 5, 2016

Record last verified: 2016-12

Locations

KR (1)