N/A
Completed N=476
Drug Use Investigation On Zithromac (Azithromycin) In HIV Patients
Source: ClinicalTrials.gov NCT01227395 ↗Enrolled (actual)
476
Serious AEs
3.2%
Results posted
Apr 2013
Primary outcomePrimary: Number of Participants With the Frequency of Treatment Related Adverse Events. — 73; 10 participants
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.
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 | — |
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.
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. Informational only — not medical advice.