N/A N=476

Drug Use Investigation On Zithromac (Azithromycin) In HIV Patients

HIV Infection

Bottom Line

View on ClinicalTrials.gov: NCT01227395 ↗

Enrolled (actual)

476

Serious AEs

3.2%

Results posted

Apr 2013

Primary outcome: Primary: Number of Participants With the Frequency of Treatment Related Adverse Events. — 73; 10 participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Azithromycin (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Pfizer
Primary completion: Mar 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With the Frequency of Treatment Related Adverse Events.	73; 10	—
PRIMARY Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.	37; 9	—
PRIMARY Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Prophylaxis).	72; 1	=0.696
PRIMARY Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Prophylaxis).	65; 8	=0.334
PRIMARY Risk Factors for the Frequency of Treatment Related Adverse Events -Concomitant Drugs (Prophylaxis).	73; 0	=1.000
PRIMARY Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Prophylaxis).	2; 71	=1.000
PRIMARY Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Prophylaxis).	28; 33	=0.015 sig
PRIMARY Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Treatment).	10; 0	=1.000
PRIMARY Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Treatment).	8; 2	=0.290
PRIMARY Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Treatment).	4; 6	=0.003 sig
PRIMARY Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Treatment).	3; 7	=0.707
SECONDARY Number of Participants That Responded to Azithromycin Treatment.	51	—
SECONDARY Number of Participants Prevented by Azithromycin Treatment.	375	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01227395). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.