Acquired Immune Deficiency Syndrome
Conditions
Keywords
Acquired Immune Deficiency Syndrome, AIDS, TMC114, Darunavir, Prezista
Brief summary
The purpose of this study is to assess the safety data of darunavir in a natural clinical practice.
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.
Interventions
DRUGNo 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.
Sponsors
Janssen Korea, Ltd., Korea
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with adverse events | Up to 30 days from end of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients with viral load | Screening, Week 12, Week 24 |
| Number of patients with CD4 T-cell count | Screening, Week 12, Week 24 |
Countries
South Korea
Outcome results
None listed