Drug Use Investigation On Zithromac (Azithromycin) In HIV Patients

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infection
• Intervention / Treatment: Drug: Azithromycin

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 Type: Observational
• Enrollment (Actual): 476

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The subjects whom an investigator involving A0661097 prescribes the Azithromycin Tablets 600mg (Zithromac Tablets 600mg).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Azithromycin; Patients taking Azithromycin.	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.; Other Names: Zithromac, Zithromax, Azithromycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Altmarc Inc.

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: July 1, 2002
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: October 7, 2010
• First Submitted That Met QC Criteria: October 21, 2010
• First Posted (Estimate): October 25, 2010

Study Record Updates

• Last Update Posted (Estimate): April 26, 2013
• Last Update Submitted That Met QC Criteria: April 18, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: HIV; Post Marketing Surveillance
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Anti-Infective Agents; Anti-Bacterial Agents; Azithromycin
• Other Study ID Numbers: A0661097