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Safety And Efficacy Of Rifabutin In HIV Patients

Last updated on November 14, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-tuberculous Mycobacterial Diseases (Including MAC Disease), Tuberculosis, Inhibition of Disseminated Mycobacterium Avium Complex (MAC) Disease Associated With HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patients not administered Mycobutin®.

NCT00810446
Pfizer
Active, not recruiting
Safety And Efficacy Of Rifabutin In HIV Patients

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Descriptive Information
Brief TitleSafety And Efficacy Of Rifabutin In HIV Patients
Official TitleDRUG USE INVESTIGATION FOR HIV INFECTION PATIENTS OF MYCOBUTIN (REGULATORY POST MARKETING COMMITMENT PLAN).
Brief SummaryThe 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 DescriptionAll 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 TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationThe 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
InterventionDrug: 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/Cohortsrifabutin
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 StatusCompleted
Actual Enrollment
 (submitted: June 29, 2018)
72
Original Estimated Enrollment
 (submitted: December 17, 2008)
500
Actual Study Completion DateMarch 2018
Actual Primary Completion DateMarch 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
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00810446
Other Study ID NumbersA0061007
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2019

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