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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00810446 |
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.
Condition | Intervention | Phase |
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Non-Tuberculous Mycobacterial Diseases (Including MAC Disease) Tuberculosis Inhibition of Disseminated Mycobacterium Avium Complex (MAC) Disease Associated With HIV Infections HIV Infections |
Drug: rifabutin |
Phase IV |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Drug Use Investigation For HIV Infection Patients Of Mycobutin (Regulatory Post Marketing Commitment Plan). |
Estimated Enrollment: | 500 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | March 2017 |
Estimated Primary Completion Date: | March 2017 (Final data collection date for primary outcome measure) |
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.".
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
The patients whom an investigator involving A0061007 prescribes the Mycobutin®.
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A0061007 |
Study First Received: | December 17, 2008 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00810446 |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Bacterial Infections Sexually Transmitted Diseases, Viral Rifabutin Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Mycobacterium Infections, Atypical Mycobacterium avium-intracellulare Infection Virus Diseases |
Gram-Positive Bacterial Infections HIV Infections Sexually Transmitted Diseases Mycobacterium Infections Tuberculosis Mycobacterium avium complex infection Retroviridae Infections |
Communicable Diseases Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Immune System Diseases Infection Actinomycetales Infections |
Pharmacologic Actions Antibiotics, Antitubercular Anti-Bacterial Agents Therapeutic Uses Lentivirus Infections Antitubercular Agents |