Drug Use Investigation On Zithromac (Azithromycin) In HIV Patients

Completed

• Conditions: HIV Infection
• Interventions: Drug: Azithromycin

• Registration Number: NCT01227395
• Lead Sponsor: Pfizer

Brief Summary

The investigation will be conducted for the purpose of determining the condition of occurrence of Adverse Events under the actual post-marketing use of Zithromac 600mg Tablet, verifying the therapeutic effects, detecting unknown Adverse Drug Reactions and drug interactions and determining the factors affecting safety and efficacy.

Detailed Description

All the patients whom an investigator prescribes the first Zithromac Tablets 600mg should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Study Timeline

• Study Start: 2002-07
• Study First Submitted: 2010-10-07
• Study First Submitted QC: 2010-10-21
• Study First Posted: 2010-10-25
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Results First Submitted: 2013-03-04
• Results First Submitted QC: 2013-03-04
• Status Verified: 2013-04
• Results First Posted: 2013-04-16
• Last Update Submitted: 2013-04-18
• Last Update Posted: 2013-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 476

Inclusion Criteria

Patients need to be administered Zithromac Tablets 600mg in order to be enrolled in the surveillance.

Exclusion Criteria

Patients not administered Zithromac Tablets 600mg.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Azithromycin	Azithromycin	Patients taking Azithromycin.

Primary Outcome Measures

Name	Time	Method
Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Treatment).	9 years(MAX)	Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without renal dysfunction is significant risk factor.
Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.	9 years(MAX)	Adverse events mean all unfavorable events that occur in participants after administration of Azithromycin, irrespective of causal relationship to Azithromycin (including clinically problematic abnormal changes in laboratory test values). Number of Treatment Related Adverse Events were evaluated in company with the causal relationship to Azithromycin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.
Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Prophylaxis).	9 years(MAX)	Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor.
Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Prophylaxis).	9 years(MAX)	Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether \<65 years or \>=65 years is significant risk factor.
Number of Participants With the Frequency of Treatment Related Adverse Events.	9 years(MAX)	Adverse events mean all unfavorable events that occur in participants after administration of Azithromycin, irrespective of causal relationship to Azithromycin (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Azithromycin.
Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Treatment).	9 years(MAX)	Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor.
Risk Factors for the Frequency of Treatment Related Adverse Events -Concomitant Drugs (Prophylaxis).	9 years(MAX)	Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether with or without concomitant drugs is significant risk factor.
Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Prophylaxis).	9 years(MAX)	Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor.
Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Treatment).	9 years(MAX)	Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor.
Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Prophylaxis).	9 years(MAX)	Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without renal dysfunction is significant risk factor.
Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Treatment).	9 years(MAX)	Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether \<65 years or \>=65 years is significant risk factor.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Prevented by Azithromycin Treatment.	9 years(MAX)	The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results.
Number of Participants That Responded to Azithromycin Treatment.	9 years(MAX)	The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results.