Drug Use Investigation On Zithromac (Azithromycin) In HIV Patients

An observational study of HIV Infection, run by Pfizer.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The investigation will be conducted for the purpose of determining the condition of occurrence of Adverse Events under the actual post-marketing use of Zithromac 600mg Tablet, verifying the therapeutic effects, detecting unknown Adverse Drug Reactions and drug interactions and determining the factors affecting safety… Read more about this study

Who is it for?: Any age
Conditions the study is for: HIV Infection
What is being tested?: Azithromycin
How many people: 476 participants
Where: No sites listed yet
Study dates: Jul 2002to Mar 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: The subjects whom an investigator involving A0661097 prescribes the Azithromycin Tablets 600mg (Zithromac Tablets 600mg).

Who may be able to join

Patients need to be administered Zithromac Tablets 600mg in order to be enrolled in the surveillance.

Who cannot join

Patients not administered Zithromac Tablets 600mg.

About this study

Official title: Drug Use Investigation On Zithromac Tablets 600mg In HIV Patients (Post Marketing Commitment Plan)

Read the detailed description

All the patients whom an investigator prescribes the first Zithromac Tablets 600mg should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Conditions: HIV Infection
Being tested: Azithromycin
Keywords: HIV, Post Marketing Surveillance
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AzithromycinDrug
Also called Zithromac, Zithromax, 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.

Study groups in NCT01227395
Study group	Role	What they receive
Azithromycin		Patients taking Azithromycin. Receives: Drug: Azithromycin

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With the Frequency of Treatment Related Adverse Events.
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.
Measured: 9 years(MAX)
Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.
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.
Measured: 9 years(MAX)
Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Prophylaxis).
Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether <65 years or >=65 years is significant risk factor.
Measured: 9 years(MAX)
Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Prophylaxis).
Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor.
Measured: 9 years(MAX)
Risk Factors for the Frequency of Treatment Related Adverse Events -Concomitant Drugs (Prophylaxis).
Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether with or without concomitant drugs is significant risk factor.
Measured: 9 years(MAX)
Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Prophylaxis).
Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without renal dysfunction is significant risk factor.
Measured: 9 years(MAX)
Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Prophylaxis).
Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor.
Measured: 9 years(MAX)
Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Treatment).
Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether <65 years or >=65 years is significant risk factor.
Measured: 9 years(MAX)
Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Treatment).
Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor.
Measured: 9 years(MAX)
Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Treatment).
Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without renal dysfunction is significant risk factor.
Measured: 9 years(MAX)
Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Treatment).
Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor.
Measured: 9 years(MAX)

Secondary outcomes (2)

Number of Participants That Responded to Azithromycin Treatment.
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.
Measured: 9 years(MAX)
Number of Participants Prevented by Azithromycin Treatment.
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.
Measured: 9 years(MAX)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2002Mar 2012

First posted25 Oct 2010 (estimated)
Study startJul 2002
Primary completionMar 2012
Study completionMar 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIV InfectionStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Retrospective
Enrolment: 476 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01227395
Sponsor's protocol ID: A0661097
Status last verified: Apr 2013
First submitted: 7 Oct 2010
Last updated: 26 Apr 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All HIV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Drug Use Investigation On Zithromac Tablets 600mg In HIV Patients (Post Marketing Commitment Plan)
ClinicalTrials.gov ID: NCT01227395
Acronym / sponsor ID: A0661097
Conditions: HIV Infection
Keywords: HIV, Post Marketing Surveillance
Study type: Observational
Recruitment status: Completed
Enrolment: 476 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Collaborators: Altmarc Inc.
Study start: Jul 2002
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 25 Oct 2010 (estimated)
Results: Posted 16 Apr 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case only
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Azithromycin	–	Drug: AzithromycinPatients taking Azithromycin.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: The subjects whom an investigator involving A0661097 prescribes the Azithromycin Tablets 600mg (Zithromac Tablets 600mg).

Key inclusion criteria (1 listed)

Patients need to be administered Zithromac Tablets 600mg in order to be enrolled in the surveillance.

Key exclusion criteria (1 listed)

Patients not administered Zithromac Tablets 600mg.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AzithromycinAlso: Zithromac, Zithromax, AzithromycinInhibition 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.	Drug	Azithromycin

Primary outcome

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.

2 secondary outcomes

Number of Participants That Responded to Azithromycin Treatment.
Time frame: 9 years(MAX)
Number of Participants Prevented by Azithromycin Treatment.
Time frame: 9 years(MAX)

Results and safety

Results posted to the registry on 16 Apr 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Azithromycin for Prophylaxis	391	391
Azithromycin for Treatment	85	84

Primary outcome: Number of Participants With the Frequency of Treatment Related Adverse Events.

Time frame: 9 years(MAX). Number. Unit: participants

Measure	Azithromycin for Prophylaxis n = 391	Azithromycin for Treatment n = 84
Value	73	10

Population analysed: No statistical analysis provided for the frequency of treatment related adverse events.

Primary outcome: Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.

Time frame: 9 years(MAX). Number. Unit: Events

Measure	Azithromycin for Prophylaxis n = 391	Azithromycin for Treatment n = 84
Value	37	9

Population analysed: No statistical analysis provided for the number of the unlisted treatment related adverse events in Japanese Package Insert.

Primary outcome: Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Prophylaxis).

Time frame: 9 years(MAX). Number. Unit: participants

Measure	<65 Years n = 381	>=65 Years n = 10
Value	72	1

<65 Years vs >=65 Years: p =0.696, Fisher Exact

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

Primary outcome: Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Prophylaxis).

Time frame: 9 years(MAX). Number. Unit: participants

Measure	Male n = 360	Female n = 31
Value	65	8

Male vs Female: p =0.334, Fisher Exact

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

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Azithromycin for Prophylaxis	11 of 391 (2.8%)	62 of 391 (15.9%)	Not reported
Azithromycin for Treatment	4 of 84 (4.8%)	6 of 84 (7.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infection, run by Pfizer.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With the Frequency of Treatment Related Adverse Events. (time frame: 9 years(MAX)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01227395.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2013.