Safety And Efficacy Of Rescriptor In Patients For Human Immunodeficiency Virus (HIV) Patients
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the Local Product Document (LPD) (unlisted adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Drug Use Investigation For Rescriptor (Regulatory Post Marketing Commitment Plan)|
- Number of Participants Who Reported Unlisted Adverse Drug Reaction. [ Time Frame: One Year ] [ Designated as safety issue: Yes ]Adverse drug reaction that is not listed in the Japanese Package Insert(Same as Local product Document).
- Number of Participants Who Improved in Number of HIV- Ribonucleic Acid (RNA) Copies, Cluster of Differentiation 4(CD4) Count, and Not Progress in HIV Classification: Centers for Disease Control and Prevention Clinical Category (CDC Category). [ Time Frame: One year ] [ Designated as safety issue: No ]
Improvement of number of HIV-RNA copies; Improvement is measured by general evaluation of decrease in HIV-RNA copies.
Improvement of CD4 counts; Improvement is measured by general evaluation of increase in CD4 counts.
Not progress in HIV classification (severity of CDC category); Subjects were classified based on the severity of CDC category as mild (Category A), moderate (Category B), and severe (Category C). No change categories from Category A to Category B / Category C, or from Category B to Category C in CDC category.
|Study Start Date:||December 2003|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-HIV drugs."
Other Name: Rescripter
All the patients whom an investigator prescribes the first Rescriptor® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.