Safety And Efficacy Of Rifabutin In HIV Patients
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|ClinicalTrials.gov Identifier: NCT00810446|
Recruitment Status : Active, not recruiting
First Posted : December 18, 2008
Last Update Posted : April 3, 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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00810446
|Study Director:||Pfizer CT.gov Call Center||Pfizer|