An observational study in HIV Infection, sponsored by Pfizer. Completed. Per ClinicalTrials.gov, last updated 2013-04-26.
Sponsored by Pfizer · Observational
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.
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.
4,259 studies on the registry are indexed under HIV Infections; 241 are open to participants now.
This study's enrollment of 476 is above the median of 200 across 713 observational studies indexed under HIV Infections.
Browse HIV Infections studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
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The subjects whom an investigator involving A0661097 prescribes the Azithromycin Tablets 600mg (Zithromac Tablets 600mg).
Patients need to be administered Zithromac Tablets 600mg in order to be enrolled in the surveillance.
Exclusion Criteria:
Patients not administered Zithromac Tablets 600mg.
Patients taking Azithromycin.
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.
Also known as: Zithromac, Zithromax, Azithromycin
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.
| Milestone | Azithromycin for Prophylaxis | Azithromycin for Treatment |
|---|---|---|
| Started | 391 | 85 |
| Completed | 391 | 84 |
| Not completed | 0 | 1 |
| Withdrew: Protocol violation | 0 | 1 |
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.
| participants | Azithromycin for Prophylaxis | Azithromycin for Treatment |
|---|---|---|
| Number of Participants With the Frequency of Treatment Related Adverse Events. | 73 | 10 |
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.
| Events | Azithromycin for Prophylaxis | Azithromycin for Treatment |
|---|---|---|
| Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert. | 37 | 9 |
Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether \<65 years or \>=65 years is significant risk factor.
| participants | <65 Years | >=65 Years |
|---|---|---|
| Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Prophylaxis). | 72 | 1 |
Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor.
| participants | Male | Female |
|---|---|---|
| Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Prophylaxis). | 65 | 8 |
Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether with or without concomitant drugs is significant risk factor.
| participants | Azithromycin With Concomitant Drugs | Azithromycin Without Concomitant Drugs |
|---|---|---|
| Risk Factors for the Frequency of Treatment Related Adverse Events -Concomitant Drugs (Prophylaxis). | 73 | 0 |
Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without renal dysfunction is significant risk factor.
| participants | Azithromycin With Renal Dysfunction | Azithromycin Without Renal Dysfunction |
|---|---|---|
| Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Prophylaxis). | 2 | 71 |
Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor.
| participants | Azithromycin With Allergies | Azithromycin Without Allergies |
|---|---|---|
| Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Prophylaxis). | 28 | 33 |
Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether \<65 years or \>=65 years is significant risk factor.
| participants | <65 Years | >=65 Years |
|---|---|---|
| Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Treatment). | 10 | 0 |
Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor.
| participants | Male | Female |
|---|---|---|
| Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Treatment). | 8 | 2 |
Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without renal dysfunction is significant risk factor.
| participants | Azithromycin With Renal Dysfunction | Azithromycin Without Renal Dysfunction |
|---|---|---|
| Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Treatment). | 4 | 6 |
Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor.
| participants | Azithromycin With Allergies | Azithromycin Without Allergies |
|---|---|---|
| Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Treatment). | 3 | 7 |
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.
| participants | Azithromycin for Treatment |
|---|---|
| Number of Participants That Responded to Azithromycin Treatment. | 51 |
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.
| participants | Azithromycin for Prophylaxis |
|---|---|
| Number of Participants Prevented by Azithromycin Treatment. | 375 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Azithromycin for Prophylaxis | — | 11/391 (2.8%) | 62/391 (15.9%) |
| Azithromycin for Treatment | — | 4/84 (4.8%) | 6/84 (7.1%) |
| Event | Azithromycin for Prophylaxis | Azithromycin for Treatment |
|---|---|---|
| Progressive multifocal leukoencephalopathyInfections and infestations | 0/391 | 1/84 |
| AnaemiaBlood and lymphatic system disorders | 2/391 | 1/84 |
| Renal failure acuteRenal and urinary disorders | 0/391 | 1/84 |
| Renal disorderRenal and urinary disorders | 0/391 | 1/84 |
| Hepatic function abnormalHepatobiliary disorders | 3/391 | 0/84 |
| Idiopathic thrombocytopenic purpuraBlood and lymphatic system disorders | 1/391 | 0/84 |
| PancytopeniaBlood and lymphatic system disorders | 1/391 | 0/84 |
| HypokalaemiaMetabolism and nutrition disorders | 1/391 | 0/84 |
| HyponatraemiaMetabolism and nutrition disorders | 1/391 | 0/84 |
| Duodenal stenosisGastrointestinal disorders | 1/391 | 0/84 |
| Event | Azithromycin for Prophylaxis | Azithromycin for Treatment |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 10/391 | 1/84 |
| HyperlipidaemiaMetabolism and nutrition disorders | 5/391 | 1/84 |
| NauseaGastrointestinal disorders | 5/391 | 0/84 |
| Hepatic function abnormalHepatobiliary disorders | 5/391 | 1/84 |
| HyperbilirubinaemiaHepatobiliary disorders | 5/391 | 0/84 |
| HyperthyroidismEndocrine disorders | 1/391 | 1/84 |
| HypoacusisEar and labyrinth disorders | 0/391 | 1/84 |
| DeafnessEar and labyrinth disorders | 0/391 | 1/84 |
| Gastrooesophageal reflux diseaseGastrointestinal disorders | 0/391 | 1/84 |
| RashSkin and subcutaneous tissue disorders | 2/391 | 1/84 |
| Age, Customized(participants) | Azithromycin for Prophylaxis | Azithromycin for Treatment | Total |
|---|---|---|---|
| <65 years | 381 | 83 | 464 |
| >=65 years | 10 | 1 | 11 |
| Sex: Female, Male(Participants) | Azithromycin for Prophylaxis | Azithromycin for Treatment | Total |
|---|---|---|---|
| Female | 31 | 9 | 40 |
| Male | 360 | 75 | 435 |
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