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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
Results First Posted : August 2, 2019
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Conditions Non-tuberculous Mycobacterial Diseases
Tuberculosis
Inhibition of Disseminated Mycobacterium Avium Complex Disease Associated With HIV Infections
Intervention Drug: rifabutin
Enrollment 72
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MYCOBUTIN Capsules (Rifabutin)
Hide Arm/Group Description Participants who received MYCOBUTIN Capsules as indicated in the approved local product document were observed from the start date of MYCOBUTIN Capsules administration to the completion/discontinuation. The maximum period was 8.5 years for prevention of disseminated Mycobacterium avium complex (MAC) infection in HIV and 6.5 years for treatment of tuberculosis and nontuberculous mycobacteriosis (NTM) including MAC infection. The dosage can be adjusted as per physician’s discretion.
Period Title: Overall Study
Started 72
Completed 72
Not Completed 0
Arm/Group Title MYCOBUTIN Capsules (Rifabutin)
Hide Arm/Group Description Participants who received MYCOBUTIN Capsules as indicated in the approved local product document were observed from the start date of MYCOBUTIN Capsules administration to the completion/discontinuation. The maximum period was 8.5 years for prevention of disseminated Mycobacterium avium complex (MAC) infection in HIV and 6.5 years for treatment of tuberculosis and nontuberculous mycobacteriosis (NTM) including MAC infection. The dosage can be adjusted as per physician’s discretion.
Overall Number of Baseline Participants 72
Hide Baseline Analysis Population Description
A total of 72 participants were registered in this study. There was no participant excluded from the baseline analysis.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 72 participants
<15 years 0
≥15 and <65 years 69
≥65 years 3
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 72 participants
Male 69
Female 3
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 72 participants
Japanese 64
Others 8
Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 72 participants
MAC (Therapeutic) 31
MAC (Preventive) 0
Tuberculosis 30
NTM Infection Other Than MAC 8
MAC (Therapeutic) and NTM Infection Other Than MAC 2
Others 1
1.Primary Outcome
Title Number of Patients With Adverse Drug Reactions in This Surveillance
Hide Description 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.
Time Frame 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set comprised of participants who satisfied the inclusion criteria and had received MYCOBUTIN Capsules at least once.
Arm/Group Title MYCOBUTIN Capsules (Rifabutin)
Hide Arm/Group Description:
Participants who received MYCOBUTIN Capsules as indicated in the approved local product document were observed from the start date of MYCOBUTIN Capsules administration to the completion/discontinuation. The maximum period was 8.5 years for prevention of disseminated Mycobacterium avium complex (MAC) infection in HIV and 6.5 years for treatment of tuberculosis and nontuberculous mycobacteriosis (NTM) including MAC infection. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 72
Measure Type: Number
Unit of Measure: Participants
ADR 16
Serious ADR 7
2.Primary Outcome
Title The Number of Participants Who Experienced an Adverse Drug Reaction Not Expected From the Local Product Document (Unknown Adverse Drug Reactions)
Hide Description 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.
Time Frame 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set comprised of participants who satisfied the inclusion criteria and had received MYCOBUTIN Capsules at least once.
Arm/Group Title MYCOBUTIN Capsules (Rifabutin)
Hide Arm/Group Description:
Participants who received MYCOBUTIN Capsules as indicated in the approved local product document were observed from the start date of MYCOBUTIN Capsules administration to the completion/discontinuation. The maximum period was 8.5 years for prevention of disseminated Mycobacterium avium complex (MAC) infection in HIV and 6.5 years for treatment of tuberculosis and nontuberculous mycobacteriosis (NTM) including MAC infection. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 72
Measure Type: Number
Unit of Measure: Participants
7
3.Primary Outcome
Title Number of Participants With Adverse Drug Reactions by Gender
Hide Description 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.
Time Frame 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set comprised of participants who satisfied the inclusion criteria and had received MYCOBUTIN Capsules at least once.
Arm/Group Title MYCOBUTIN Capsules (Rifabutin)
Hide Arm/Group Description:
Participants who received MYCOBUTIN Capsules as indicated in the approved local product document were observed from the start date of MYCOBUTIN Capsules administration to the completion/discontinuation. The maximum period was 8.5 years for prevention of disseminated Mycobacterium avium complex (MAC) infection in HIV and 6.5 years for treatment of tuberculosis and nontuberculous mycobacteriosis (NTM) including MAC infection. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 72
Measure Type: Number
Unit of Measure: Participants
Male Number Analyzed 69 participants
16
Female Number Analyzed 3 participants
0
4.Primary Outcome
Title Number of Participants With Adverse Drug Reactions by Age
Hide Description 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.
Time Frame 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set comprised of participants who satisfied the inclusion criteria and had received MYCOBUTIN Capsules at least once.
Arm/Group Title MYCOBUTIN Capsules (Rifabutin)
Hide Arm/Group Description:
Participants who received MYCOBUTIN Capsules as indicated in the approved local product document were observed from the start date of MYCOBUTIN Capsules administration to the completion/discontinuation. The maximum period was 8.5 years for prevention of disseminated Mycobacterium avium complex (MAC) infection in HIV and 6.5 years for treatment of tuberculosis and nontuberculous mycobacteriosis (NTM) including MAC infection. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 72
Measure Type: Number
Unit of Measure: Participants
<15 years Number Analyzed 0 participants
≥15 and <65 years Number Analyzed 69 participants
16
≥65 years Number Analyzed 3 participants
0
5.Primary Outcome
Title Number of Participants With Adverse Drug Reactions by Diagnosis
Hide Description 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.
Time Frame 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set comprised of participants who satisfied the inclusion criteria and had received MYCOBUTIN Capsules at least once.
Arm/Group Title MYCOBUTIN Capsules (Rifabutin)
Hide Arm/Group Description:
Participants who received MYCOBUTIN Capsules as indicated in the approved local product document were observed from the start date of MYCOBUTIN Capsules administration to the completion/discontinuation. The maximum period was 8.5 years for prevention of disseminated Mycobacterium avium complex (MAC) infection in HIV and 6.5 years for treatment of tuberculosis and nontuberculous mycobacteriosis (NTM) including MAC infection. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 72
Measure Type: Number
Unit of Measure: Participants
MAC (Therapeutic) Number Analyzed 31 participants
7
MAC (Preventive) Number Analyzed 0 participants
Tuberculosis Number Analyzed 30 participants
8
NTM Infections Other Than MAC Number Analyzed 8 participants
0
MAC (Therapeutic) and NTM Infection Other Than MAC Number Analyzed 2 participants
1
Others Number Analyzed 1 participants
0
6.Primary Outcome
Title Clinical Response Rate (Therapeutic)
Hide Description 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.
Time Frame 6.5 years (at maximum)
Hide Outcome Measure Data
Hide Analysis Population Description
The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at the final observation point. Participants assessed as "indeterminable (n=10)" at the final observation were excluded.
Arm/Group Title MYCOBUTIN Capsules (Rifabutin)
Hide Arm/Group Description:
Participants who received MYCOBUTIN Capsules as indicated in the approved local product document were observed from the start date of MYCOBUTIN Capsules administration to the completion/discontinuation. The maximum period was 8.5 years for prevention of disseminated Mycobacterium avium complex (MAC) infection in HIV and 6.5 years for treatment of tuberculosis and nontuberculous mycobacteriosis (NTM) including MAC infection. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 72
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
80.6
(68.63 to 89.58)
7.Primary Outcome
Title Clinical Response Rate (Therapeutic) by Gender
Hide Description 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.
Time Frame 6.5 years (at maximum)
Hide Outcome Measure Data
Hide Analysis Population Description
The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at the final observation point. Participants assessed as "indeterminable (n=10)" at the final observation were excluded.
Arm/Group Title MYCOBUTIN Capsules (Rifabutin)
Hide Arm/Group Description:
Participants who received MYCOBUTIN Capsules as indicated in the approved local product document were observed from the start date of MYCOBUTIN Capsules administration to the completion/discontinuation. The maximum period was 8.5 years for prevention of disseminated Mycobacterium avium complex (MAC) infection in HIV and 6.5 years for treatment of tuberculosis and nontuberculous mycobacteriosis (NTM) including MAC infection. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 72
Measure Type: Number
Unit of Measure: Percentage of Participants
Male Number Analyzed 60 participants
80.0
Female Number Analyzed 2 participants
100.0
8.Primary Outcome
Title Clinical Response Rate (Therapeutic) by Age
Hide Description 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.
Time Frame 6.5 years (at maximum)
Hide Outcome Measure Data
Hide Analysis Population Description
The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at the final observation point. Participants assessed as "indeterminable (n=10)" at the final observation were excluded.
Arm/Group Title MYCOBUTIN Capsules (Rifabutin)
Hide Arm/Group Description:
Participants who received MYCOBUTIN Capsules as indicated in the approved local product document were observed from the start date of MYCOBUTIN Capsules administration to the completion/discontinuation. The maximum period was 8.5 years for prevention of disseminated Mycobacterium avium complex (MAC) infection in HIV and 6.5 years for treatment of tuberculosis and nontuberculous mycobacteriosis (NTM) including MAC infection. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 72
Measure Type: Number
Unit of Measure: Percentage of Participants
<15 years Number Analyzed 0 participants
≥15 and <65 years Number Analyzed 60 participants
80.0
≥65 years Number Analyzed 2 participants
100.0
9.Primary Outcome
Title Clinical Response Rate (Therapeutic) by Diagnosis
Hide Description 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.
Time Frame 6.5 years (at maximum)
Hide Outcome Measure Data
Hide Analysis Population Description
The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at the final observation point. Participants assessed as "indeterminable (n=10)" at the final observation were excluded.
Arm/Group Title MYCOBUTIN Capsules (Rifabutin)
Hide Arm/Group Description:
Participants who received MYCOBUTIN Capsules as indicated in the approved local product document were observed from the start date of MYCOBUTIN Capsules administration to the completion/discontinuation. The maximum period was 8.5 years for prevention of disseminated Mycobacterium avium complex (MAC) infection in HIV and 6.5 years for treatment of tuberculosis and nontuberculous mycobacteriosis (NTM) including MAC infection. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 72
Measure Type: Number
Unit of Measure: Percentage of Participants
MAC (Therapeutic) Number Analyzed 23 participants
78.3
Tuberculosis Number Analyzed 29 participants
89.7
NTM Infections Other Than MAC Number Analyzed 7 participants
57.1
MAC (Therapeutic) and NTM Infection Other Than MAC Number Analyzed 2 participants
50.0
Others Number Analyzed 1 participants
100.0
Time Frame 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
Adverse Event Reporting Description The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
 
Arm/Group Title MYCOBUTIN Capsules (Rifabutin)
Hide Arm/Group Description Participants who received MYCOBUTIN Capsules as indicated in the approved local product document were observed from the start date of MYCOBUTIN Capsules administration to the completion/discontinuation. The maximum period was 8.5 years for prevention of disseminated Mycobacterium avium complex (MAC) infection in HIV and 6.5 years for treatment of tuberculosis and nontuberculous mycobacteriosis (NTM) including MAC infection. The dosage can be adjusted as per physician’s discretion.
All-Cause Mortality
MYCOBUTIN Capsules (Rifabutin)
Affected / at Risk (%)
Total   2/72 (2.78%) 
Hide Serious Adverse Events
MYCOBUTIN Capsules (Rifabutin)
Affected / at Risk (%)
Total   15/72 (20.83%) 
Blood and lymphatic system disorders   
Pancytopenia * 1  2/72 (2.78%) 
Eye disorders   
Necrotising retinitis * 1  1/72 (1.39%) 
Gastrointestinal disorders   
Nausea * 1  2/72 (2.78%) 
Vomiting * 1  1/72 (1.39%) 
General disorders   
Drug resistance * 1  1/72 (1.39%) 
Immune system disorders   
Immune reconstitution inflammatory syndrome * 1  4/72 (5.56%) 
Infections and infestations   
Cytomegalovirus chorioretinitis * 1  3/72 (4.17%) 
Mycobacterium avium complex infection * 1  1/72 (1.39%) 
Arthritis bacterial * 1  1/72 (1.39%) 
Herpes zoster * 1  1/72 (1.39%) 
Cerebral toxoplasmosis * 1  1/72 (1.39%) 
Lung infection * 1  1/72 (1.39%) 
Subcutaneous abscess * 1  1/72 (1.39%) 
Atypical mycobacterial infection * 1  1/72 (1.39%) 
Injury, poisoning and procedural complications   
Lumbar vertebral fracture * 1  1/72 (1.39%) 
Spinal compression fracture * 1  1/72 (1.39%) 
Investigations   
Platelet count decreased * 1  1/72 (1.39%) 
White blood cell count decreased * 1  1/72 (1.39%) 
Musculoskeletal and connective tissue disorders   
Osteoporosis * 1  1/72 (1.39%) 
Psychiatric disorders   
Irritability * 1  1/72 (1.39%) 
Hallucination, auditory * 1  1/72 (1.39%) 
Bipolar disorder * 1  1/72 (1.39%) 
Anxiety * 1  1/72 (1.39%) 
Depressive symptom * 1  1/72 (1.39%) 
Renal and urinary disorders   
Renal disorder * 1  1/72 (1.39%) 
Skin and subcutaneous tissue disorders   
Erythema multiforme * 1  1/72 (1.39%) 
1
Term from vocabulary, MedDRA 19.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.0%
MYCOBUTIN Capsules (Rifabutin)
Affected / at Risk (%)
Total   28/72 (38.89%) 
Gastrointestinal disorders   
Nausea * 1  2/72 (2.78%) 
Hepatobiliary disorders   
Hepatic function abnormal * 1  3/72 (4.17%) 
Immune system disorders   
Immune reconstitution inflammatory syndrome * 1  5/72 (6.94%) 
Infections and infestations   
Herpes zoster * 1  4/72 (5.56%) 
Investigations   
Blood triglycerides increased * 1  4/72 (5.56%) 
Metabolism and nutrition disorders   
Hypertriglyceridaemia * 1  2/72 (2.78%) 
Hyperlipidaemia * 1  2/72 (2.78%) 
Renal and urinary disorders   
Renal impairment * 1  4/72 (5.56%) 
Skin and subcutaneous tissue disorders   
Rash * 1  2/72 (2.78%) 
1
Term from vocabulary, MedDRA 19.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00810446    
Other Study ID Numbers: A0061007
First Submitted: December 17, 2008
First Posted: December 18, 2008
Results First Submitted: February 8, 2019
Results First Posted: August 2, 2019
Last Update Posted: August 2, 2019