A Study to Assess the Safety and Effectiveness of Darunavir for Treating Human Immunodeficiency Virus-Type I (HIV-1) Infection in Filipino Patients

• 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
  
  

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.