Drug Use Investigation On Zithromac (Azithromycin) In HIV Patients

HIV Infection Clinical Trial

Official title:

Drug Use Investigation On Zithromac Tablets 600mg In HIV Patients (Post Marketing Commitment Plan)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01227395
• Other study ID #: A0661097
• Status: Completed
• Phase: N/A
• First received: October 7, 2010
• Last updated: April 18, 2013
• Start date: July 2002
• Est. completion date: March 2012

Study information

• Verified date: April 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 476
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• HIV Infection

Intervention

Drug:
• Azithromycin
Inhibition of onset: Perorally administer 1200mg of azithromycin (potency) once a week to adults. Treatment: Perorally administer 600mg of azithromycin (potency) once a day to adults.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Altmarc Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With the Frequency of Treatment Related Adverse Events.	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.	9 years(MAX)	Yes
Primary	Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.	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.	9 years(MAX)	Yes
Primary	Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Prophylaxis).	Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether <65 years or >=65 years is significant risk factor.	9 years(MAX)	Yes
Primary	Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Prophylaxis).	Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor.	9 years(MAX)	Yes
Primary	Risk Factors for the Frequency of Treatment Related Adverse Events -Concomitant Drugs (Prophylaxis).	Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether with or without concomitant drugs is significant risk factor.	9 years(MAX)	Yes
Primary	Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Prophylaxis).	Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without renal dysfunction is significant risk factor.	9 years(MAX)	Yes
Primary	Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Prophylaxis).	Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor.	9 years(MAX)	Yes
Primary	Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Treatment).	Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether <65 years or >=65 years is significant risk factor.	9 years(MAX)	Yes
Primary	Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Treatment).	Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor.	9 years(MAX)	Yes
Primary	Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Treatment).	Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without renal dysfunction is significant risk factor.	9 years(MAX)	Yes
Primary	Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Treatment).	Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor.	9 years(MAX)	Yes
Secondary	Number of Participants That Responded to Azithromycin Treatment.	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.	9 years(MAX)	No
Secondary	Number of Participants Prevented by Azithromycin Treatment.	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.	9 years(MAX)	No

External Links

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