Drug Use Investigation On Zithromac (Azithromycin) In HIV Patients

This study has been completed.
Sponsor:
Collaborator:
Altmarc Inc.
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01227395
First received: October 7, 2010
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

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 Intervention
HIV Infection
Drug: Azithromycin

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Drug Use Investigation On Zithromac Tablets 600mg In HIV Patients (Post Marketing Commitment Plan)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With the Frequency of Treatment Related Adverse Events. [ Time Frame: 9 years(MAX) ] [ Designated as safety issue: Yes ]
    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.

  • Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert. [ Time Frame: 9 years(MAX) ] [ Designated as safety issue: Yes ]
    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.

  • Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Prophylaxis). [ Time Frame: 9 years(MAX) ] [ Designated as safety issue: Yes ]
    Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether <65 years or >=65 years is significant risk factor.

  • Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Prophylaxis). [ Time Frame: 9 years(MAX) ] [ Designated as safety issue: Yes ]
    Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor.

  • Risk Factors for the Frequency of Treatment Related Adverse Events -Concomitant Drugs (Prophylaxis). [ Time Frame: 9 years(MAX) ] [ Designated as safety issue: Yes ]
    Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether with or without concomitant drugs is significant risk factor.

  • Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Prophylaxis). [ Time Frame: 9 years(MAX) ] [ Designated as safety issue: Yes ]
    Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without renal dysfunction is significant risk factor.

  • Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Prophylaxis). [ Time Frame: 9 years(MAX) ] [ Designated as safety issue: Yes ]
    Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor.

  • Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Treatment). [ Time Frame: 9 years(MAX) ] [ Designated as safety issue: Yes ]
    Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether <65 years or >=65 years is significant risk factor.

  • Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Treatment). [ Time Frame: 9 years(MAX) ] [ Designated as safety issue: Yes ]
    Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor.

  • Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Treatment). [ Time Frame: 9 years(MAX) ] [ Designated as safety issue: Yes ]
    Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without renal dysfunction is significant risk factor.

  • Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Treatment). [ Time Frame: 9 years(MAX) ] [ Designated as safety issue: Yes ]
    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:
  • Number of Participants That Responded to Azithromycin Treatment. [ Time Frame: 9 years(MAX) ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Prevented by Azithromycin Treatment. [ Time Frame: 9 years(MAX) ] [ Designated as safety issue: No ]
    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.


Enrollment: 476
Study Start Date: July 2002
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227395

Sponsors and Collaborators
Pfizer
Altmarc Inc.
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01227395     History of Changes
Other Study ID Numbers: A0661097
Study First Received: October 7, 2010
Results First Received: March 4, 2013
Last Updated: April 18, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Pfizer:
HIV
Post Marketing Surveillance

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014