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Trial record 1 of 1 for:    NCT00810446
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Safety And Efficacy Of Rifabutin In HIV Patients

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ClinicalTrials.gov Identifier: NCT00810446
Recruitment Status : Completed
First Posted : December 18, 2008
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date December 17, 2008
First Posted Date December 18, 2008
Last Update Posted Date July 2, 2018
Actual Study Start Date June 11, 2009
Actual Primary Completion Date March 26, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 17, 2008)
  • The incidence of adverse drug reactions in this surveillance. [ Time Frame: 8.5 Years (MAX) ]
  • Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). [ Time Frame: 8.5 Years (MAX) ]
  • Factors considered to affect the safety and/or efficacy of this drug. [ Time Frame: 8.5 Years (MAX) ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00810446 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Safety And Efficacy Of Rifabutin In HIV Patients
Official Title Drug Use Investigation For Hiv Infection Patients Of Mycobutin (Regulatory Post Marketing Commitment Plan).
Brief Summary 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.
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The patients whom an investigator involving A0061007 prescribes the Mycobutin®.
Condition
  • Non-tuberculous Mycobacterial Diseases
  • Tuberculosis
  • Inhibition of Disseminated Mycobacterium Avium Complex Disease Associated With HIV Infections
Intervention 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
Study Groups/Cohorts rifabutin
Patients administered Rifabutin.
Intervention: Drug: rifabutin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 29, 2018)
72
Original Estimated Enrollment
 (submitted: December 17, 2008)
500
Actual Study Completion Date March 26, 2018
Actual Primary Completion Date March 26, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients not administered Mycobutin®.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00810446
Other Study ID Numbers A0061007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2018