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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
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
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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.
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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 
Overall Participants Analyzed 
[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) ]
  Hide Outcome Measure 6

Measure Type Primary
Measure Title Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Prophylaxis).
Measure Description Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without renal dysfunction is significant risk factor.
Time Frame 9 years(MAX)  

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.
The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.

Reporting Groups
  Description
Azithromycin With Renal Dysfunction Participants with renal dysfunction who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
Azithromycin Without Renal Dysfunction Participants without renal dysfunction who taking Azithromycin for Prophylaxis according to Japanese Package Insert.

Measured Values
   Azithromycin With Renal Dysfunction   Azithromycin Without Renal Dysfunction 
Participants Analyzed 
[Units: Participants]
 13   378 
Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Prophylaxis). 
[Units: Participants]
 2   71 


Statistical Analysis 1 for Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Prophylaxis).
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Fisher Exact
P Value [4] =1.000
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The risk factor tested was "Renal Dysfunction". The null hypothesis is there is no difference between "with and without renal dysfunction " in the frequency of Treatment Related Adverse Events(TRAEs).
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
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[3] Other relevant method information, such as adjustments or degrees of freedom:
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[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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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