Safety And Efficacy Of Rifabutin In HIV Patients
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.
Non-tuberculous Mycobacterial Diseases (Including MAC Disease)
Inhibition of Disseminated Mycobacterium Avium Complex (MAC) Disease Associated With HIV Infections
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Drug Use Investigation For Hiv Infection Patients Of Mycobutin (Regulatory Post Marketing Commitment Plan).|
- The incidence of adverse drug reactions in this surveillance. [ Time Frame: 8.5 Years (MAX) ] [ Designated as safety issue: Yes ]
- Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). [ Time Frame: 8.5 Years (MAX) ] [ Designated as safety issue: Yes ]
- Factors considered to affect the safety and/or efficacy of this drug. [ Time Frame: 8.5 Years (MAX) ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2009|
|Estimated Study Completion Date:||October 2018|
|Estimated Primary Completion Date:||October 2018 (Final data collection date for primary outcome measure)|
Patients administered Rifabutin.
Mycobutin® capsules150mg depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. " 1.Tuberculosis : The usual adult dosage for oral use is 150 mg to 300 mg of rifabutin once daily.For the treatment of multiple-drug resistance tuberculosis, the usual dosage for oral use is 300 to 450 mg of rifabutin once daily.
2.Treatment of non-tuberculous mycobacterial diseases (including MAC disease) : The usual adult dosage for oral use is 300 mg of rifabutin once daily.
3.Inhibition of disseminated Mycobacterium avium complex (MAC) disease associated with HIV infections : The usual adult dosage for oral use is 300 mg of rifabutin once daily.".
Other Name: Mycobutin
All the patients whom an investigator prescribes the first Mycobutin® 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: NCT00810446
|Study Director:||Pfizer CT.gov Call Center||Pfizer|