Drug Use Investigation On Zithromac (Azithromycin) In HIV Patients

NCT ID: NCT01227395

Last Updated: 2013-04-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

476 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-07-31

Study Completion Date

2012-03-31

Brief Summary

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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

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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.

Conditions

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HIV Infection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Azithromycin

Patients taking Azithromycin.

Azithromycin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Zithromac, Zithromax, Azithromycin

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Altmarc Inc.

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Other Identifiers

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A0661097

Identifier Type: -

Identifier Source: org_study_id

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