Safety And Efficacy Of Rifabutin In HIV Patients

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: December 17, 2008
Last updated: February 6, 2015
Last verified: February 2015

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)
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).

Resource links provided by NLM:

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 ]

Estimated Enrollment: 500
Study Start Date: June 2009
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


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®.


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
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Please refer to this study by its identifier: NCT00810446

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer Identifier: NCT00810446     History of Changes
Other Study ID Numbers: A0061007
Study First Received: December 17, 2008
Last Updated: February 6, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Mycobacterium Infections
Mycobacterium avium-intracellulare Infection
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections, Nontuberculous
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antitubercular
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses processed this record on March 26, 2015