HIV Infection
Conditions
Keywords
HIV, Post Marketing Surveillance
Brief 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 and efficacy.
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.
Interventions
DRUGAzithromycin
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.
Sponsors
Altmarc Inc.
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Treatment). | 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 -Gender (Treatment). | 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). | 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. |
| Number of Participants With the Frequency of Treatment Related Adverse Events. | 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. | 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). | 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). | 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). | 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). | 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). | 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). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Prevented by Azithromycin Treatment. | 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 That Responded to Azithromycin Treatment. | 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. |
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Azithromycin for Prophylaxis Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert. | 391 |
| Azithromycin for Treatment Participants taking Azithromycin for Treatment according to Japanese Package Insert. | 84 |
| Total | 475 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Azithromycin for Prophylaxis | Azithromycin for Treatment | Total |
|---|---|---|---|
| Age, Customized <65 years | 381 participants | 83 participants | 464 participants |
| Age, Customized >=65 years | 10 participants | 1 participants | 11 participants |
| Sex: Female, Male Female | 31 Participants | 9 Participants | 40 Participants |
| Sex: Female, Male Male | 360 Participants | 75 Participants | 435 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 62 / 391 | 6 / 84 |
| serious Total, serious adverse events | 11 / 391 | 4 / 84 |
Outcome results
Primary
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.
Time frame: 9 years(MAX)
Population: No statistical analysis provided for the frequency of treatment related adverse events.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azithromycin for Prophylaxis | Number of Participants With the Frequency of Treatment Related Adverse Events. | 73 participants |
| Azithromycin for Treatment | Number of Participants With the Frequency of Treatment Related Adverse Events. | 10 participants |
Primary
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.
Time frame: 9 years(MAX)
Population: No statistical analysis provided for the number of the unlisted treatment related adverse events in Japanese Package Insert.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azithromycin for Prophylaxis | Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert. | 37 Events |
| Azithromycin for Treatment | Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert. | 9 Events |
Primary
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.
Time frame: 9 years(MAX)
Population: The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azithromycin for Prophylaxis | Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Prophylaxis). | 72 participants |
| Azithromycin for Treatment | Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Prophylaxis). | 1 participants |
Comparison: The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years in the frequency of Treatment Related Adverse Events(TRAEs).p-value: =0.696Fisher Exact
Primary
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.
Time frame: 9 years(MAX)
Population: The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azithromycin for Prophylaxis | Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Treatment). | 10 participants |
| Azithromycin for Treatment | Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Treatment). | 0 participants |
Comparison: The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years in the frequency of Treatment Related Adverse Events(TRAEs).p-value: =1Fisher Exact
Primary
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.
Time frame: 9 years(MAX)
Population: The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azithromycin for Prophylaxis | Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Prophylaxis). | 28 participants |
| Azithromycin for Treatment | Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Prophylaxis). | 33 participants |
Comparison: The risk factor tested was Allergies. The null hypothesis is there is no difference between with and without allergies in the frequency of Treatment Related Adverse Events(TRAEs).p-value: =0.015Fisher Exact
Primary
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.
Time frame: 9 years(MAX)
Population: The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azithromycin for Prophylaxis | Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Treatment). | 3 participants |
| Azithromycin for Treatment | Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Treatment). | 7 participants |
Comparison: The risk factor tested was Allergies. The null hypothesis is there is no difference between with and without allergies in the frequency of Treatment Related Adverse Events(TRAEs).p-value: =0.707Fisher Exact
Primary
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.
Time frame: 9 years(MAX)
Population: The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drugs was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azithromycin for Prophylaxis | Risk Factors for the Frequency of Treatment Related Adverse Events -Concomitant Drugs (Prophylaxis). | 73 participants |
| Azithromycin for Treatment | Risk Factors for the Frequency of Treatment Related Adverse Events -Concomitant Drugs (Prophylaxis). | 0 participants |
Comparison: The risk factor tested was concomitant drugs. The null hypothesis is there is no difference between with and without concomitant drugs in the frequency of Treatment Related Adverse Events(TRAEs).p-value: =1Fisher Exact
Primary
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.
Time frame: 9 years(MAX)
Population: The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azithromycin for Prophylaxis | Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Prophylaxis). | 65 participants |
| Azithromycin for Treatment | Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Prophylaxis). | 8 participants |
Comparison: The risk factor tested was Gender. The null hypothesis is there is no difference between Male and Female in the frequency of Treatment Related Adverse Events(TRAEs).p-value: =0.334Fisher Exact
Primary
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.
Time frame: 9 years(MAX)
Population: The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azithromycin for Prophylaxis | Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Treatment). | 8 participants |
| Azithromycin for Treatment | Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Treatment). | 2 participants |
Comparison: The risk factor tested was Gender. The null hypothesis is there is no difference between Male and Female in the frequency of Treatment Related Adverse Events(TRAEs).p-value: =0.29Fisher Exact
Primary
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.
Time frame: 9 years(MAX)
Population: The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azithromycin for Prophylaxis | Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Prophylaxis). | 2 participants |
| Azithromycin for Treatment | Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Prophylaxis). | 71 participants |
Comparison: 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).p-value: =1Fisher Exact
Primary
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.
Time frame: 9 years(MAX)
Population: The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azithromycin for Prophylaxis | Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Treatment). | 4 participants |
| Azithromycin for Treatment | Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Treatment). | 6 participants |
Comparison: 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).p-value: =0.003Fisher Exact
Secondary
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.
Time frame: 9 years(MAX)
Population: The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azithromycin for Prophylaxis | Number of Participants Prevented by Azithromycin Treatment. | 375 participants |
Secondary
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.
Time frame: 9 years(MAX)
Population: The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azithromycin for Prophylaxis | Number of Participants That Responded to Azithromycin Treatment. | 51 participants |