Clinical Trials

MainTitle

Safety And Efficacy Of Rifabutin In HIV Patients

This study has been completed
Sponsor
Pfizer


Information provided by (Responsible Party)
Pfizer
ClinicalTrials.gov Identifier
NCT00810446

First received: December 17, 2008
Last updated: June 13, 2019
Last Verified: June 2019
History of Changes
Purpose

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
Non-tuberculous Mycobacterial Diseases
Tuberculosis
Inhibition of Disseminated Mycobacterium Avium Complex Disease Associated With HIV Infections

Drug : rifabutin

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).

Further study details as provided by Pfizer:

Primary Outcome Measures

  • Number of Patients With Adverse Drug Reactions in This Surveillance [ Time Frame: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive) ]
    An adverse drug reaction (ADR) was any untoward medical occurrence attributed to MYCOBUTIN Capsules in a participant who received MYCOBUTIN Capsules. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to MYCOBUTIN Capsules was assessed by the physician.
  • The Number of Participants Who Experienced an Adverse Drug Reaction Not Expected From the Local Product Document (Unknown Adverse Drug Reactions) [ Time Frame: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive) ]
    An adverse drug reaction (ADR) was any untoward medical occurrence attributed to MYCOBUTIN Capsules in a participant who received MYCOBUTIN Capsules. Relatedness to MYCOBUTIN Capsules was assessed by the physician. Expectedness of the adverse drug reaction was determined according to the Japanese package insert.
  • Number of Participants With Adverse Drug Reactions by Gender [ Time Frame: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive) ]
    An adverse drug reaction (ADR) was any untoward medical occurrence attributed to MYCOBUTIN Capsules in a participant who received MYCOBUTIN Capsules. Relatedness to MYCOBUTIN Capsules was assessed by the physician. Participants with ADRs were counted by gender to access whether it was a risk factor for the ADR.
  • Number of Participants With Adverse Drug Reactions by Age [ Time Frame: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive) ]
    An adverse drug reaction (ADR) was any untoward medical occurrence attributed to MYCOBUTIN Capsules in a participant who received MYCOBUTIN Capsules. Relatedness to MYCOBUTIN Capsules was assessed by the physician. Participants with ADRs were counted by age to assess whether it was a risk factor for the ADR.
  • Number of Participants With Adverse Drug Reactions by Diagnosis [ Time Frame: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive) ]
    An adverse drug reaction (ADR) was any untoward medical occurrence attributed to MYCOBUTIN Capsules in a participant who received MYCOBUTIN Capsules. Relatedness to MYCOBUTIN Capsules was assessed by the physician. Participants with ADRs were counted by diagnosis to assess whether it was a risk factor for the ADR.
  • Clinical Response Rate (Therapeutic) [ Time Frame: 6.5 years (at maximum) ]
    Clinical response rate was defined as the percentage of participants who achieved clinical response over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical efficacy of MYCOBUTIN Capsules were determined by the investigator at the final observation point based on clinical symptoms and examinations, according to the following categories: (1) markedly improved, (2) improved, (3) slightly improved (4) unchanged, (5) aggravated, or (6) indeterminable. The participants assessed as (1) markedly improved and (2) improved were considered to have achieved clinical response.
  • Clinical Response Rate (Therapeutic) by Gender [ Time Frame: 6.5 years (at maximum) ]
    Clinical response rate was defined as the percentage of participants who achieved clinical response over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical efficacy of MYCOBUTIN Capsules were determined by the investigator at the final observation point based on clinical symptoms and examinations, according to the following categories: (1) markedly improved, (2) improved, (3) slightly improved (4) unchanged, (5) aggravated, or (6) indeterminable. The participants assessed as (1) markedly improved and (2) improved were considered to have achieved clinical response. Participants who achieved clinical response by gender were counted to assess whether it contributed to clinical response.
  • Clinical Response Rate (Therapeutic) by Age [ Time Frame: 6.5 years (at maximum) ]
    Clinical response rate was defined as the percentage of participants who achieved clinical response over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical efficacy of MYCOBUTIN Capsules were determined by the investigator at the final observation point based on clinical symptoms and examinations, according to the following categories: (1) markedly improved, (2) improved, (3) slightly improved (4) unchanged, (5) aggravated, or (6) indeterminable. The participants assessed as (1) markedly improved and (2) improved were considered to have achieved clinical response. Participants who achieved clinical response by age were counted to assess whether it contributed to clinical response.
  • Clinical Response Rate (Therapeutic) by Diagnosis [ Time Frame: 6.5 years (at maximum) ]
    Clinical response rate was defined as the percentage of participants who achieved clinical response over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical efficacy of MYCOBUTIN Capsules were determined by the investigator at the final observation point based on clinical symptoms and examinations, according to the following categories: (1) markedly improved, (2) improved, (3) slightly improved (4) unchanged, (5) aggravated, or (6) indeterminable. The participants assessed as (1) markedly improved and (2) improved were considered to have achieved clinical response. Participants who achieved clinical response by diagnosis were counted to assess whether it contributed to clinical response.

Enrollment: 72
Study Start Date: June 2009
Study Completion Date: March 2018
Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)

Arms 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.

Eligibility

Eligibility

Ages Eligible for Study: Child, Adult, Senior  
Sexes Eligible for Study: All  
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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810446

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center Pfizer
More Information

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Responsible Party: Pfizer  
ClinicalTrials.gov Identifier: NCT00810446   History of Changes  
Other Study ID Numbers: A0061007  
Study First Received: December 17, 2008  
Last Updated: June 13, 2019  
Individual Participant Data    
Plan to Share IPD: No  

Additional relevant MeSH terms:
Infection
Tuberculosis
Mycobacterium Infections
Mycobacterium avium-intracellulare Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Rifabutin

ClinicalTrials.gov processed this data on June 01, 2020
This information is provided by ClinicalTrials.gov.