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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This was a phase 4, observational, open-label study conducted in participants who were prescribed azithromycin by their treating physician per usual clinical practice. Study drug was not provided by the Sponsor.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Participant Flow:   Overall Study
    Azithromycin for Prophylaxis     Azithromycin for Treatment  
STARTED     391     85  
COMPLETED     391     84  
NOT COMPLETED     0     1  
Protocol Violation                 0                 1  



  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
  Show All Outcome Measures

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
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Time Frame No text entered.
Additional Description The frequency of treatment related advers events during the study.

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.

Serious Adverse Events
    Azithromycin for Prophylaxis     Azithromycin for Treatment  
Total, serious adverse events      
# participants affected / at risk     11/391 (2.81%)     4/84 (4.76%)  
Blood and lymphatic system disorders      
Idiopathic thrombocytopenic purpura † 1    
# participants affected / at risk     1/391 (0.26%)     0/84 (0.00%)  
# events     1     0  
Pancytopenia † 1    
# participants affected / at risk     1/391 (0.26%)     0/84 (0.00%)  
# events     1     0  
Anaemia † 1    
# participants affected / at risk     2/391 (0.51%)     1/84 (1.19%)  
# events     2     1  
Gastrointestinal disorders      
Duodenal stenosis † 1    
# participants affected / at risk     1/391 (0.26%)     0/84 (0.00%)  
# events     1     0  
Hepatobiliary disorders      
Hepatic function abnormal † 1    
# participants affected / at risk     3/391 (0.77%)     0/84 (0.00%)  
# events     3     0  
Liver disorder † 1    
# participants affected / at risk     1/391 (0.26%)     0/84 (0.00%)  
# events     1     0  
Infections and infestations      
Progressive multifocal leukoencephalopathy † 1    
# participants affected / at risk     0/391 (0.00%)     1/84 (1.19%)  
# events     0     1  
Investigations      
White blood cell count decreased † 1    
# participants affected / at risk     1/391 (0.26%)     0/84 (0.00%)  
# events     1     0  
Metabolism and nutrition disorders      
Hypokalaemia † 1    
# participants affected / at risk     1/391 (0.26%)     0/84 (0.00%)  
# events     1     0  
Hyponatraemia † 1    
# participants affected / at risk     1/391 (0.26%)     0/84 (0.00%)  
# events     1     0  
Renal and urinary disorders      
Renal impairment † 1    
# participants affected / at risk     1/391 (0.26%)     0/84 (0.00%)  
# events     1     0  
Renal failure acute † 1    
# participants affected / at risk     0/391 (0.00%)     1/84 (1.19%)  
# events     0     1  
Renal disorder † 1    
# participants affected / at risk     0/391 (0.00%)     1/84 (1.19%)  
# events     0     1  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA-J 14.1




  Other Adverse Events


  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.


Limitations and Caveats
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
No text entered.  


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