Drug Use Investigation On Zithromac (Azithromycin) In HIV Patients
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ClinicalTrials.gov Identifier: NCT01227395 |
Recruitment Status
:
Completed
First Posted
: October 25, 2010
Results First Posted
: April 16, 2013
Last Update Posted
: April 26, 2013
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Condition or disease | Intervention/treatment |
---|---|
HIV Infection | Drug: Azithromycin |
Study Type : | Observational |
Actual Enrollment : | 476 participants |
Observational Model: | Case-Only |
Time Perspective: | Retrospective |
Official Title: | Drug Use Investigation On Zithromac Tablets 600mg In HIV Patients (Post Marketing Commitment Plan) |
Study Start Date : | July 2002 |
Actual Primary Completion Date : | March 2012 |
Actual Study Completion Date : | March 2012 |

Group/Cohort | Intervention/treatment |
---|---|
Azithromycin
Patients taking Azithromycin.
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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
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- Number of Participants With the Frequency of Treatment Related Adverse Events. [ Time Frame: 9 years(MAX) ]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) ]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) ]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) ]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) ]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) ]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) ]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) ]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) ]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) ]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) ]Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor.
- Number of Participants That Responded to Azithromycin Treatment. [ Time Frame: 9 years(MAX) ]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) ]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.

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01227395
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT01227395 History of Changes |
Other Study ID Numbers: |
A0661097 |
First Posted: | October 25, 2010 Key Record Dates |
Results First Posted: | April 16, 2013 |
Last Update Posted: | April 26, 2013 |
Last Verified: | April 2013 |
Keywords provided by Pfizer:
HIV Post Marketing Surveillance |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |