A Study to Assess the Safety and Effectiveness of Darunavir for Treating Human Immunodeficiency Virus-Type I (HIV-1) Infection in Filipino Patients
The purpose of this study is to assess the safety and effectiveness of darunavir for the treatment human immunodeficiency virus-type I (HIV-1) infection among Filipino adults.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||A Post-Marketing Surveillance Study on the Safety and Effectiveness of Darunavir on Filipino Patients With Human Immunodeficiency Virus-Type I (HIV-1) Infection|
- Number of patients with incidence of adverse events [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
- Number of patients with incidence of discontinuation of study medication due to adverse events [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
- Mean decrease of viral load at the end of treatment from baseline [ Time Frame: Baseline, Week 12, and Week 24 ] [ Designated as safety issue: No ]
- Number of patients with viral load of 50 copies per ml at the end of treatment [ Time Frame: Baseline, Week 12, and Week 24 ] [ Designated as safety issue: No ]
- Number of patients with lack of effect [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]Any failure of expected pharmacologic action of the study medication
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Patients will be taking darunavir as per the dosing regimen given on product insert approved in Philippines.
Drug: No intervention
This is an observational study. Darunavir will be administered as per the recommended doses and will be given orally every 4 weeks for a period of 24 weeks. For treatment-naive and treatment-experienced adult patients with no darunavir resistance associated substitutions: Darunavir 800 mg will be administered with ritonavir 100 mg once daily with food. For treatment-experienced adult patients with at least one darunavir resistance associated substitution: Darunavir 600 mg will be administered with ritonavir 200 mg twice daily with food.
This is an open-label (all people know the identity of the intervention), multi-center (study conducted at multiple sites), uncontrolled (all the patients receiving darunavir) clinical and observational study (study in which the investigators/physicians observe the patients and measure their outcomes) to evaluate the safety and effectiveness of darunavir for the treatment human immunodeficiency virus-type 1 (HIV-1) infection among adult Filipino patients. The study will enroll 10 percentage of patient who would use the product, as a requirement of the Philippine Food and Drug Administration (FDA). Patients will be monitored from baseline and every 4 weeks thereafter for a period of 24 weeks. Safety evaluations for adverse events, clinical laboratory tests, physical examination, concomitant medications, and co-morbid conditions will be monitored throughout the study. The duration of treatment will be for 24 weeks and the total study will be conducted for 3 years.