Safety And Efficacy Of Rescriptor In Patients For Human Immunodeficiency Virus (HIV) Patients
|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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823966
|Study Director:||Pfizer CT.gov Call Center||Pfizer|