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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

October 7, 2010
April 18, 2013
July 2002
March 2012   (final data collection date for primary outcome measure)
  • 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.
  • Risk factors likely to affect the frequency of treatment related adverse events. [ Time Frame: 9 years(MAX) ] [ Designated as safety issue: Yes ]
  • The frequency of treatment related adverse events. [ Time Frame: 9 years(MAX) ] [ Designated as safety issue: Yes ]
  • Unlisted treatment related adverse events. [ Time Frame: 9 years(MAX) ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01227395 on ClinicalTrials.gov Archive Site
  • 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.
  • The proportion of responders to azithromycin treatment. [ Time Frame: 9 years(MAX) ] [ Designated as safety issue: No ]
  • The Inhibition of onset rate by azithromycin treatment. [ Time Frame: 9 years(MAX) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

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

HIV Infection
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
Azithromycin
Patients taking Azithromycin.
Intervention: Drug: Azithromycin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
476
March 2012
March 2012   (final data collection date for primary outcome measure)

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.

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01227395
A0661097
No
Pfizer
Pfizer
Altmarc Inc.
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP