Safety And Efficacy Of Maraviroc In Patients For HIV Patients (Regulatory Post Marketing Commitment Plan)
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown 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: Retrospective
|Official Title:||Drug Use Investigation For HIV Infection Patients Of Maraviroc (Regulatory Post Marketing Commitment Plan)|
- The incidence of adverse drug reactions in this surveillance. [ Time Frame: 9 years (MAX) ] [ Designated as safety issue: Yes ]
- Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). [ Time Frame: 9 years (MAX) ] [ Designated as safety issue: Yes ]
- Factors considered to affect the safety and/or efficacy of this drug. [ Time Frame: 9 years (MAX) ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||March 2019|
|Estimated Primary Completion Date:||March 2019 (Final data collection date for primary outcome measure)|
Drug: CELSENTRI® Tablets
CELSENTRI ® Tablets 150mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food".
Other Name: CELSENTRI® Tablets, maraviroc, Selzentry
All the patients whom an investigator prescribes the first CELSENTRI® Tablets should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00864474
|Study Director:||Pfizer CT.gov Call Center||Pfizer|