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
Results First Received: March 4, 2013  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Retrospective
Condition: HIV Infection
Intervention: Drug: Azithromycin

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Azithromycin for Prophylaxis Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
Azithromycin for Treatment Participants taking Azithromycin for Treatment according to Japanese Package Insert.
Total Total of all reporting groups

Baseline Measures
    Azithromycin for Prophylaxis     Azithromycin for Treatment     Total  
Number of Participants  
[units: participants]
  391     84     475  
Age, Customized  
[units: participants]
     
<65 years     381     83     464  
>=65 years     10     1     11  
Gender  
[units: participants]
     
Female     31     9     40  
Male     360     75     435  



  Outcome Measures
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1.  Primary:   Number of Participants With the Frequency of Treatment Related Adverse Events.   [ Time Frame: 9 years(MAX) ]

2.  Primary:   Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.   [ Time Frame: 9 years(MAX) ]

3.  Primary:   Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Prophylaxis).   [ Time Frame: 9 years(MAX) ]

4.  Primary:   Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Prophylaxis).   [ Time Frame: 9 years(MAX) ]

5.  Primary:   Risk Factors for the Frequency of Treatment Related Adverse Events -Concomitant Drugs (Prophylaxis).   [ Time Frame: 9 years(MAX) ]

6.  Primary:   Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Prophylaxis).   [ Time Frame: 9 years(MAX) ]

7.  Primary:   Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Prophylaxis).   [ Time Frame: 9 years(MAX) ]

8.  Primary:   Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Treatment).   [ Time Frame: 9 years(MAX) ]

9.  Primary:   Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Treatment).   [ Time Frame: 9 years(MAX) ]

10.  Primary:   Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Treatment).   [ Time Frame: 9 years(MAX) ]

11.  Primary:   Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Treatment).   [ Time Frame: 9 years(MAX) ]

12.  Secondary:   Number of Participants That Responded to Azithromycin Treatment.   [ Time Frame: 9 years(MAX) ]

13.  Secondary:   Number of Participants Prevented by Azithromycin Treatment.   [ Time Frame: 9 years(MAX) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


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