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

History of Changes

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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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) ]

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2. Primary:

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

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3. Primary:

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

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4. Primary:

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

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5. Primary:

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

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6. Primary:

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

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7. Primary:

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

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8. Primary:

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

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9. Primary:

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

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10. Primary:

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

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11. Primary:

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

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12. Secondary:

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

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13. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

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
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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

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