Trial Outcomes & Findings for Drug Use Investigation On Zithromac (Azithromycin) In HIV Patients (NCT NCT01227395)

Last Updated: 2013-04-26

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

476 participants

Primary outcome timeframe

9 years(MAX)

Results posted on

2013-04-26

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	391	85
Overall Study COMPLETED	391	84
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Protocol Violation	0	1

Baseline Characteristics

Drug Use Investigation On Zithromac (Azithromycin) In HIV Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Azithromycin for Prophylaxis n=391 Participants Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.	Azithromycin for Treatment n=84 Participants Participants taking Azithromycin for Treatment according to Japanese Package Insert.	Total n=475 Participants Total of all reporting groups
Age, Customized <65 years	381 participants n=5 Participants	83 participants n=7 Participants	464 participants n=5 Participants
Age, Customized >=65 years	10 participants n=5 Participants	1 participants n=7 Participants	11 participants n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	9 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	360 Participants n=5 Participants	75 Participants n=7 Participants	435 Participants n=5 Participants

PRIMARY outcome

Timeframe: 9 years(MAX)

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

Outcome measures

Outcome measures
Measure	Azithromycin for Prophylaxis n=391 Participants Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.	Azithromycin for Treatment n=84 Participants Participants taking Azithromycin for Treatment according to Japanese Package Insert.
Number of Participants With the Frequency of Treatment Related Adverse Events.	73 participants	10 participants

PRIMARY outcome

Timeframe: 9 years(MAX)

Population: No statistical analysis provided for the number of the 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.

Outcome measures

Outcome measures
Measure	Azithromycin for Prophylaxis n=391 Participants Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.	Azithromycin for Treatment n=84 Participants Participants taking Azithromycin for Treatment according to Japanese Package Insert.
Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.	37 Events	9 Events

PRIMARY outcome

Timeframe: 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.

Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether \<65 years or \>=65 years is significant risk factor.

Outcome measures

Outcome measures
Measure	Azithromycin for Prophylaxis n=381 Participants Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.	Azithromycin for Treatment n=10 Participants Participants taking Azithromycin for Treatment according to Japanese Package Insert.
Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Prophylaxis).	72 participants	1 participants

PRIMARY outcome

Timeframe: 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.

Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor.

Outcome measures

Outcome measures
Measure	Azithromycin for Prophylaxis n=360 Participants Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.	Azithromycin for Treatment n=31 Participants Participants taking Azithromycin for Treatment according to Japanese Package Insert.
Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Prophylaxis).	65 participants	8 participants

PRIMARY outcome

Timeframe: 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.

Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether with or without concomitant drugs is significant risk factor.

Outcome measures

Outcome measures
Measure	Azithromycin for Prophylaxis n=387 Participants Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.	Azithromycin for Treatment n=4 Participants Participants taking Azithromycin for Treatment according to Japanese Package Insert.
Risk Factors for the Frequency of Treatment Related Adverse Events -Concomitant Drugs (Prophylaxis).	73 participants	0 participants

PRIMARY outcome

Timeframe: 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.

Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without renal dysfunction is significant risk factor.

Outcome measures

Outcome measures
Measure	Azithromycin for Prophylaxis n=13 Participants Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.	Azithromycin for Treatment n=378 Participants Participants taking Azithromycin for Treatment according to Japanese Package Insert.
Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Prophylaxis).	2 participants	71 participants

PRIMARY outcome

Timeframe: 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.

Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor.

Outcome measures

Outcome measures
Measure	Azithromycin for Prophylaxis n=108 Participants Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.	Azithromycin for Treatment n=226 Participants Participants taking Azithromycin for Treatment according to Japanese Package Insert.
Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Prophylaxis).	28 participants	33 participants

PRIMARY outcome

Timeframe: 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.

Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether \<65 years or \>=65 years is significant risk factor.

Outcome measures

Outcome measures
Measure	Azithromycin for Prophylaxis n=83 Participants Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.	Azithromycin for Treatment n=1 Participants Participants taking Azithromycin for Treatment according to Japanese Package Insert.
Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Treatment).	10 participants	0 participants

PRIMARY outcome

Timeframe: 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.

Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor.

Outcome measures

Outcome measures
Measure	Azithromycin for Prophylaxis n=75 Participants Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.	Azithromycin for Treatment n=9 Participants Participants taking Azithromycin for Treatment according to Japanese Package Insert.
Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Treatment).	8 participants	2 participants

PRIMARY outcome

Timeframe: 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.

Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without renal dysfunction is significant risk factor.

Outcome measures

Outcome measures
Measure	Azithromycin for Prophylaxis n=7 Participants Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.	Azithromycin for Treatment n=77 Participants Participants taking Azithromycin for Treatment according to Japanese Package Insert.
Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Treatment).	4 participants	6 participants

PRIMARY outcome

Timeframe: 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.

Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor.

Outcome measures

Outcome measures
Measure	Azithromycin for Prophylaxis n=19 Participants Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.	Azithromycin for Treatment n=56 Participants Participants taking Azithromycin for Treatment according to Japanese Package Insert.
Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Treatment).	3 participants	7 participants

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Azithromycin for Prophylaxis n=64 Participants Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.	Azithromycin for Treatment Participants taking Azithromycin for Treatment according to Japanese Package Insert.
Number of Participants That Responded to Azithromycin Treatment.	51 participants	—

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Azithromycin for Prophylaxis n=390 Participants Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.	Azithromycin for Treatment Participants taking Azithromycin for Treatment according to Japanese Package Insert.
Number of Participants Prevented by Azithromycin Treatment.	375 participants	—

Adverse Events

Azithromycin for Prophylaxis

Serious events: 11 serious events

Other events: 62 other events

Deaths: 0 deaths

Azithromycin for Treatment

Serious events: 4 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Azithromycin for Prophylaxis n=391 participants at risk Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.	Azithromycin for Treatment n=84 participants at risk Participants taking Azithromycin for Treatment according to Japanese Package Insert.
Infections and infestations Progressive multifocal leukoencephalopathy	0.00% 0/391 The frequency of treatment related advers events during the study.	1.2% 1/84 • Number of events 1 The frequency of treatment related advers events during the study.
Blood and lymphatic system disorders Idiopathic thrombocytopenic purpura	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Blood and lymphatic system disorders Pancytopenia	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Blood and lymphatic system disorders Anaemia	0.51% 2/391 • Number of events 2 The frequency of treatment related advers events during the study.	1.2% 1/84 • Number of events 1 The frequency of treatment related advers events during the study.
Metabolism and nutrition disorders Hypokalaemia	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Metabolism and nutrition disorders Hyponatraemia	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Gastrointestinal disorders Duodenal stenosis	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Hepatobiliary disorders Hepatic function abnormal	0.77% 3/391 • Number of events 3 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Hepatobiliary disorders Liver disorder	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Renal and urinary disorders Renal impairment	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Renal and urinary disorders Renal failure acute	0.00% 0/391 The frequency of treatment related advers events during the study.	1.2% 1/84 • Number of events 1 The frequency of treatment related advers events during the study.
Renal and urinary disorders Renal disorder	0.00% 0/391 The frequency of treatment related advers events during the study.	1.2% 1/84 • Number of events 1 The frequency of treatment related advers events during the study.
Investigations White blood cell count decreased	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Azithromycin for Prophylaxis n=391 participants at risk Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.	Azithromycin for Treatment n=84 participants at risk Participants taking Azithromycin for Treatment according to Japanese Package Insert.
Infections and infestations Hepatitis C	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Infections and infestations Oral candidiasis	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Blood and lymphatic system disorders Lymphadenopathy	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Blood and lymphatic system disorders Anaemia	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Immune system disorders Hypersensitivity	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Endocrine disorders Hyperthyroidism	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	1.2% 1/84 • Number of events 1 The frequency of treatment related advers events during the study.
Metabolism and nutrition disorders Hypercalcaemia	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Metabolism and nutrition disorders Hypercholesterolaemia	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Metabolism and nutrition disorders Hypertriglyceridaemia	1.0% 4/391 • Number of events 4 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Metabolism and nutrition disorders Hyperlipidaemia	1.3% 5/391 • Number of events 5 The frequency of treatment related advers events during the study.	1.2% 1/84 • Number of events 1 The frequency of treatment related advers events during the study.
Metabolism and nutrition disorders Diabetes mellitus	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Psychiatric disorders Depression	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Psychiatric disorders Abnormal dreams	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Nervous system disorders Headache	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Nervous system disorders Neuropathy peripheral	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Ear and labyrinth disorders Hypoacusis	0.00% 0/391 The frequency of treatment related advers events during the study.	1.2% 1/84 • Number of events 1 The frequency of treatment related advers events during the study.
Ear and labyrinth disorders Deafness	0.00% 0/391 The frequency of treatment related advers events during the study.	1.2% 1/84 • Number of events 1 The frequency of treatment related advers events during the study.
Cardiac disorders Bradycardia	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Gastrointestinal disorders Nausea	1.3% 5/391 • Number of events 5 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Gastrointestinal disorders Gastric ulcer	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Gastrointestinal disorders Diarrhoea	2.6% 10/391 • Number of events 10 The frequency of treatment related advers events during the study.	1.2% 1/84 • Number of events 1 The frequency of treatment related advers events during the study.
General disorders Duodenal ulcer	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Gastrointestinal disorders Abdominal discomfort	0.51% 2/391 • Number of events 2 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Gastrointestinal disorders Vomiting	0.77% 3/391 • Number of events 3 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/391 The frequency of treatment related advers events during the study.	1.2% 1/84 • Number of events 1 The frequency of treatment related advers events during the study.
Hepatobiliary disorders Hepatic function abnormal	1.3% 5/391 • Number of events 5 The frequency of treatment related advers events during the study.	1.2% 1/84 • Number of events 1 The frequency of treatment related advers events during the study.
Hepatobiliary disorders Liver disorder	0.77% 3/391 • Number of events 3 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Hepatobiliary disorders Hyperbilirubinaemia	1.3% 5/391 • Number of events 5 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Skin and subcutaneous tissue disorders Pruritus	0.51% 2/391 • Number of events 2 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Skin and subcutaneous tissue disorders Rash	0.51% 2/391 • Number of events 2 The frequency of treatment related advers events during the study.	1.2% 1/84 • Number of events 1 The frequency of treatment related advers events during the study.
Skin and subcutaneous tissue disorders Drug eruption	0.51% 2/391 • Number of events 2 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Skin and subcutaneous tissue disorders Lipodystrophy acquired	0.00% 0/391 The frequency of treatment related advers events during the study.	1.2% 1/84 • Number of events 1 The frequency of treatment related advers events during the study.
Renal and urinary disorders Renal impairment	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	1.2% 1/84 • Number of events 1 The frequency of treatment related advers events during the study.
Reproductive system and breast disorders Sexual dysfunction	0.00% 0/391 The frequency of treatment related advers events during the study.	1.2% 1/84 • Number of events 1 The frequency of treatment related advers events during the study.
General disorders Pyrexia	0.77% 3/391 • Number of events 3 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Investigations C-reactive protein increased	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Investigations Haemoglobin decreased	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Investigations Gamma-glutamyltransferase increased	1.0% 4/391 • Number of events 4 The frequency of treatment related advers events during the study.	1.2% 1/84 • Number of events 1 The frequency of treatment related advers events during the study.
Investigations Platelet count decreased	0.51% 2/391 • Number of events 2 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Investigations Blood alkaline phosphatase increased	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Investigations Blood creatinine increased	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Investigations Blood cholesterol increased	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Investigations Blood triglycerides increased	0.77% 3/391 • Number of events 3 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Investigations Blood bilirubin increased	0.51% 2/391 • Number of events 2 The frequency of treatment related advers events during the study.	1.2% 1/84 • Number of events 1 The frequency of treatment related advers events during the study.
Investigations Blood uric acid increased	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Investigations Red blood cell count decreased	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Investigations Beta 2 microglobulin urine increased	0.26% 1/391 • Number of events 1 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.
Investigations White blood cell count decreased	0.77% 3/391 • Number of events 3 The frequency of treatment related advers events during the study.	0.00% 0/84 The frequency of treatment related advers events during the study.