Overview

This trial is active, not recruiting.

Conditions non-tuberculous mycobacterial diseases (including mac disease), tuberculosis, inhibition of disseminated mycobacterium avium complex (mac) disease associated with hiv infections
Treatment rifabutin
Sponsor Pfizer
Start date June 2009
End date July 2018
Trial size 500 participants
Trial identifier NCT00810446, A0061007

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Patients administered Rifabutin.
rifabutin Mycobutin
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.".

Primary Outcomes

Measure
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)

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Patients need to be administered Mycobutin® in order to be enrolled in the surveillance. Exclusion Criteria: - Patients not administered Mycobutin®.

Additional Information

Official title Drug Use Investigation For Hiv Infection Patients Of Mycobutin (Regulatory Post Marketing Commitment Plan).
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Pfizer.