Trial record 15 of 18 for:
" December 03, 2008":" January 02, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
Safety And Efficacy Of Rifabutin In HIV Patients
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: December 17, 2008
Last updated: August 24, 2016
Last verified: August 2016
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
||Observational Model: Case-Only
Time Perspective: Prospective
||Drug Use Investigation For Hiv Infection Patients Of Mycobutin (Regulatory Post Marketing Commitment Plan).
Primary Outcome Measures:
- 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 ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 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.
|Ages Eligible for Study:
||Child, Adult, Senior
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
The patients whom an investigator involving A0061007 prescribes the Mycobutin®.
- Patients need to be administered Mycobutin® in order to be enrolled in the surveillance.
- Patients not administered Mycobutin®.
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00810446
||Pfizer CT.gov Call Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 17, 2008
||August 24, 2016
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 25, 2016
Acquired Immunodeficiency Syndrome
Mycobacterium avium-intracellulare Infection
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Gram-Positive Bacterial Infections
Mycobacterium Infections, Nontuberculous