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


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

Frequency Threshold
Threshold above which other adverse events are reported   0%  

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.

Other Adverse Events
    Azithromycin for Prophylaxis     Azithromycin for Treatment  
Total, other (not including serious) adverse events      
# participants affected / at risk     62/391     6/84  
Blood and lymphatic system disorders      
Lymphadenopathy † 1    
# participants affected / at risk     1/391 (0.26%)     0/84 (0.00%)  
# events     1     0  
Anaemia † 1    
# participants affected / at risk     1/391 (0.26%)     0/84 (0.00%)  
# events     1     0  
Cardiac disorders      
Bradycardia † 1    
# participants affected / at risk     1/391 (0.26%)     0/84 (0.00%)  
# events     1     0  
Ear and labyrinth disorders      
Hypoacusis † 1    
# participants affected / at risk     0/391 (0.00%)     1/84 (1.19%)  
# events     0     1  
Deafness † 1    
# participants affected / at risk     0/391 (0.00%)     1/84 (1.19%)  
# events     0     1  
Endocrine disorders      
Hyperthyroidism † 1    
# participants affected / at risk     1/391 (0.26%)     1/84 (1.19%)  
# events     1     1  
Gastrointestinal disorders      
Nausea † 1    
# participants affected / at risk     5/391 (1.28%)     0/84 (0.00%)  
# events     5     0  
Gastric ulcer † 1    
# participants affected / at risk     1/391 (0.26%)     0/84 (0.00%)  
# events     1     0  
Diarrhoea † 1    
# participants affected / at risk     10/391 (2.56%)     1/84 (1.19%)  
# events     10     1  
Abdominal discomfort † 1    
# participants affected / at risk     2/391 (0.51%)     0/84 (0.00%)  
# events     2     0  
Vomiting † 1    
# participants affected / at risk     3/391 (0.77%)     0/84 (0.00%)  
# events     3     0  
Gastrooesophageal reflux disease † 1    
# participants affected / at risk     0/391 (0.00%)     1/84 (1.19%)  
# events     0     1  
General disorders      
Duodenal ulcer † 1    
# participants affected / at risk     1/391 (0.26%)     0/84 (0.00%)  
# events     1     0  
Pyrexia † 1    
# participants affected / at risk     3/391 (0.77%)     0/84 (0.00%)  
# events     3     0  
Hepatobiliary disorders      
Hepatic function abnormal † 1    
# participants affected / at risk     5/391 (1.28%)     1/84 (1.19%)  
# events     5     1  
Liver disorder † 1    
# participants affected / at risk     3/391 (0.77%)     0/84 (0.00%)  
# events     3     0  
Hyperbilirubinaemia † 1    
# participants affected / at risk     5/391 (1.28%)     0/84 (0.00%)  
# events     5     0  
Immune system disorders      
Hypersensitivity † 1    
# participants affected / at risk     1/391 (0.26%)     0/84 (0.00%)  
# events     1     0  
Infections and infestations      
Hepatitis C † 1    
# participants affected / at risk     1/391 (0.26%)     0/84 (0.00%)  
# events     1     0  
Oral candidiasis † 1    
# participants affected / at risk     1/391 (0.26%)     0/84 (0.00%)  
# events     1     0  
Investigations      
C-reactive protein increased † 1    
# participants affected / at risk     1/391 (0.26%)     0/84 (0.00%)  
# events     1     0  
Haemoglobin decreased † 1    
# participants affected / at risk     1/391 (0.26%)     0/84 (0.00%)  
# events     1     0  
Gamma-glutamyltransferase increased † 1    
# participants affected / at risk     4/391 (1.02%)     1/84 (1.19%)  
# events     4     1  
Platelet count decreased † 1    
# participants affected / at risk     2/391 (0.51%)     0/84 (0.00%)  
# events     2     0  
Blood alkaline phosphatase increased † 1    
# participants affected / at risk     1/391 (0.26%)     0/84 (0.00%)  
# events     1     0  
Blood creatinine increased † 1    
# participants affected / at risk     1/391 (0.26%)     0/84 (0.00%)  
# events     1     0  
Blood cholesterol increased † 1    
# participants affected / at risk     1/391 (0.26%)     0/84 (0.00%)  
# events     1     0  
Blood triglycerides increased † 1    
# participants affected / at risk     3/391 (0.77%)     0/84 (0.00%)  
# events     3     0  
Blood bilirubin increased † 1    
# participants affected / at risk     2/391 (0.51%)     1/84 (1.19%)  
# events     2     1  
Blood uric acid increased † 1    
# participants affected / at risk     1/391 (0.26%)     0/84 (0.00%)  
# events     1     0  
Red blood cell count decreased † 1    
# participants affected / at risk     1/391 (0.26%)     0/84 (0.00%)  
# events     1     0  
Beta 2 microglobulin urine increased † 1    
# participants affected / at risk     1/391 (0.26%)     0/84 (0.00%)  
# events     1     0  
White blood cell count decreased † 1    
# participants affected / at risk     3/391 (0.77%)     0/84 (0.00%)  
# events     3     0  
Metabolism and nutrition disorders      
Hypercalcaemia † 1    
# participants affected / at risk     1/391 (0.26%)     0/84 (0.00%)  
# events     1     0  
Hypercholesterolaemia † 1    
# participants affected / at risk     1/391 (0.26%)     0/84 (0.00%)  
# events     1     0  
Hypertriglyceridaemia † 1    
# participants affected / at risk     4/391 (1.02%)     0/84 (0.00%)  
# events     4     0  
Hyperlipidaemia † 1    
# participants affected / at risk     5/391 (1.28%)     1/84 (1.19%)  
# events     5     1  
Diabetes mellitus † 1    
# participants affected / at risk     1/391 (0.26%)     0/84 (0.00%)  
# events     1     0  
Nervous system disorders      
Headache † 1    
# participants affected / at risk     1/391 (0.26%)     0/84 (0.00%)  
# events     1     0  
Neuropathy peripheral † 1    
# participants affected / at risk     1/391 (0.26%)     0/84 (0.00%)  
# events     1     0  
Psychiatric disorders      
Depression † 1    
# participants affected / at risk     1/391 (0.26%)     0/84 (0.00%)  
# events     1     0  
Abnormal dreams † 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%)     1/84 (1.19%)  
# events     1     1  
Reproductive system and breast disorders      
Sexual dysfunction † 1    
# participants affected / at risk     0/391 (0.00%)     1/84 (1.19%)  
# events     0     1  
Skin and subcutaneous tissue disorders      
Pruritus † 1    
# participants affected / at risk     2/391 (0.51%)     0/84 (0.00%)  
# events     2     0  
Rash † 1    
# participants affected / at risk     2/391 (0.51%)     1/84 (1.19%)  
# events     2     1  
Drug eruption † 1    
# participants affected / at risk     2/391 (0.51%)     0/84 (0.00%)  
# events     2     0  
Lipodystrophy acquired † 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



  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