Safety And Efficacy Of Rifabutin In HIV Patients
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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 |
---|---|---|
Non-tuberculous Mycobacterial Diseases (Including MAC Disease) Tuberculosis Inhibition of Disseminated Mycobacterium Avium Complex (MAC) Disease Associated With HIV Infections |
Drug: rifabutin |
Phase 4 |
Study Type: | Observational |
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 ]
Estimated Enrollment: | 500 |
Study Start Date: | June 2009 |
Estimated Study Completion Date: | March 2018 |
Estimated Primary Completion Date: | March 2018 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
rifabutin
Patients administered Rifabutin.
|
Drug: 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
|
Detailed Description:
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.
![](https://webarchive.library.unt.edu/web/20130305101405im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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:
- Patients need to be administered Mycobutin® in order to be enrolled in the surveillance.
Exclusion Criteria:
- Patients not administered Mycobutin®.
![](https://webarchive.library.unt.edu/web/20130305101405im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
![](https://webarchive.library.unt.edu/web/20130305101405im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Additional Information:
No publications provided
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00810446 History of Changes |
Other Study ID Numbers: | A0061007 |
Study First Received: | December 17, 2008 |
Last Updated: | February 25, 2013 |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency (PMDA) |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Mycobacterium Infections Mycobacterium avium-intracellulare Infection Tuberculosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Slow Virus Diseases Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Mycobacterium Infections, Atypical Rifabutin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antibiotics, Antitubercular Antitubercular Agents |
ClinicalTrials.gov processed this record on March 03, 2013