Safety And Efficacy Of Rifabutin In HIV Patients
|ClinicalTrials.gov Identifier: NCT00810446|
Recruitment Status : Active, not recruiting
First Posted : December 18, 2008
Last Update Posted : January 31, 2018
|Condition or disease||Intervention/treatment|
|Non-tuberculous Mycobacterial Diseases Tuberculosis Inhibition of Disseminated Mycobacterium Avium Complex Disease Associated With HIV Infections||Drug: rifabutin|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Drug Use Investigation For Hiv Infection Patients Of Mycobutin (Regulatory Post Marketing Commitment Plan).|
|Actual Study Start Date :||June 11, 2009|
|Estimated Primary Completion Date :||July 17, 2018|
|Estimated Study Completion Date :||July 17, 2018|
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
- The incidence of adverse drug reactions in this surveillance. [ Time Frame: 8.5 Years (MAX) ]
- Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). [ Time Frame: 8.5 Years (MAX) ]
- Factors considered to affect the safety and/or efficacy of this drug. [ Time Frame: 8.5 Years (MAX) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00810446
|Study Director:||Pfizer CT.gov Call Center||Pfizer|