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Safety And Efficacy Of Rifabutin In HIV Patients.
This study is not yet open for participant recruitment.
Verified by Pfizer, December 2008
Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00810446
  Purpose

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
HIV Infections
Drug: rifabutin
Phase IV

MedlinePlus related topics: AIDS Tuberculosis
Drug Information available for: Rifabutin
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: Drug Use Investigation For HIV Infection Patients Of Mycobutin (Regulatory Post Marketing Commitment Plan).

Further study details as provided by Pfizer:

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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

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)
Intervention Details:
    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.".

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The patients whom an investigator involving A0061007 prescribes the Mycobutin®.

Criteria

Inclusion Criteria:

  • Patients need to be administered Mycobutin® in order to be enrolled in the surveillance.

Exclusion Criteria:

  • Patients not administered Mycobutin®.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00810446

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 14, 2009