Drug Use Investigation On Zithromac (Azithromycin) In HIV Patients

Study Description

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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.

Condition or disease	Intervention/treatment
HIV Infection	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 Design

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Study Type :	Observational
Actual Enrollment :	476 participants
Observational Model:	Case-Only
Time Perspective:	Retrospective
Official Title:	Drug Use Investigation On Zithromac Tablets 600mg In HIV Patients (Post Marketing Commitment Plan)
Study Start Date :	July 2002
Actual Primary Completion Date :	March 2012
Actual Study Completion Date :	March 2012

Groups and Cohorts

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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 Name: Zithromac, Zithromax, Azithromycin

Outcome Measures

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Primary Outcome Measures :

1. Number of Participants With the Frequency of Treatment Related Adverse Events. [ Time Frame: 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.
2. Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert. [ Time Frame: 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.
3. Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Prophylaxis). [ Time Frame: 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.
4. Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Prophylaxis). [ Time Frame: 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.
5. Risk Factors for the Frequency of Treatment Related Adverse Events -Concomitant Drugs (Prophylaxis). [ Time Frame: 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.
6. Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Prophylaxis). [ Time Frame: 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.
7. Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Prophylaxis). [ Time Frame: 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.
8. Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Treatment). [ Time Frame: 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.
9. Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Treatment). [ Time Frame: 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.
10. Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Treatment). [ Time Frame: 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.
11. Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Treatment). [ Time Frame: 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.

Secondary Outcome Measures :

1. Number of Participants That Responded to Azithromycin Treatment. [ Time Frame: 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.
2. Number of Participants Prevented by Azithromycin Treatment. [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

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

Criteria

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.

Contacts and Locations

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Sponsors and Collaborators

Pfizer

Altmarc Inc.

Investigators

Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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Additional Information:

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

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01227395 History of Changes
Other Study ID Numbers:	A0661097
First Posted:	October 25, 2010
Results First Posted:	April 16, 2013
Last Update Posted:	April 26, 2013
Last Verified:	April 2013

Keywords provided by Pfizer:

HIV; Post Marketing Surveillance

Additional relevant MeSH terms:

HIV Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases	Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases