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Completed

NCT Number: NCT01227395

Drug Use Investigation On Zithromac (Azithromycin) In HIV Patients

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.

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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Azithromycin

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.

Other names: Zithromac, Zithromax, Azithromycin

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Altmarc Inc.

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2012
Study completion
2012
First posted
Oct 25, 2010
Registry last updated
Apr 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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