Clinical trial NCT01227395: Drug Use Investigation On Zithromac (Azithromycin) In HIV Patients
Official title: Drug Use Investigation On Zithromac Tablets 600mg In HIV Patients (Post Marketing Commitment Plan)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Keywords: HIV
Post Marketing Surveillance
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Altmarc Inc.
First posted: 2010-10-25
Enrollment: 476
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects whom an investigator involving A0661097 prescribes the Azithromycin Tablets 600mg (Zithromac Tablets 600mg).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With the Frequency of Treatment Related Adverse Events.
timeFrame: 9 years(MAX)
measure: Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.
timeFrame: 9 years(MAX)
measure: Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Prophylaxis).
timeFrame: 9 years(MAX)
measure: Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Prophylaxis).
timeFrame: 9 years(MAX)
measure: Risk Factors for the Frequency of Treatment Related Adverse Events -Concomitant Drugs (Prophylaxis).
timeFrame: 9 years(MAX)
measure: Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Prophylaxis).
timeFrame: 9 years(MAX)
measure: Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Prophylaxis).
timeFrame: 9 years(MAX)
measure: Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Treatment).
timeFrame: 9 years(MAX)
measure: Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Treatment).
timeFrame: 9 years(MAX)
measure: Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Treatment).
timeFrame: 9 years(MAX)
measure: Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Treatment).
timeFrame: 9 years(MAX)
Secondary outcomes:
measure: Number of Participants That Responded to Azithromycin Treatment.
timeFrame: 9 years(MAX)
measure: Number of Participants Prevented by Azithromycin Treatment.
timeFrame: 9 years(MAX)
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: