CompletedNot Applicable

Safety And Efficacy Of Rifabutin In HIV Patients

72 participantsStarted 2009-06

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Patients With Adverse Drug Reactions in This Surveillance

Timeframe: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)

The Number of Participants Who Experienced an Adverse Drug Reaction Not Expected From the Local Product Document (Unknown Adverse Drug Reactions)

Timeframe: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)

Number of Participants With Adverse Drug Reactions by Gender

Timeframe: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)

Number of Participants With Adverse Drug Reactions by Age

Timeframe: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)

Number of Participants With Adverse Drug Reactions by Diagnosis

Timeframe: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)

Clinical Response Rate (Therapeutic)

Timeframe: 6.5 years (at maximum)

Trial details

NCT IDNCT00810446

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-03

Results submitted2019-02-08

View on ClinicalTrials.gov More Non-tuberculous Mycobacterial Diseases trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Patients With Adverse Drug Reactions in This Surveillance

Timeframe: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)

The Number of Participants Who Experienced an Adverse Drug Reaction Not Expected From the Local Product Document (Unknown Adverse Drug Reactions)

Timeframe: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)

Number of Participants With Adverse Drug Reactions by Gender

Timeframe: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)

Number of Participants With Adverse Drug Reactions by Age

Timeframe: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)

Number of Participants With Adverse Drug Reactions by Diagnosis

Timeframe: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)

Clinical Response Rate (Therapeutic)

Timeframe: 6.5 years (at maximum)