Drug Use Investigation On Zithromac (Azithromycin) In HIV Patients
NCT01227395
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
Patients need to be administered Zithromac Tablets 600mg in order to be enrolled in the surveillance.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
Patients not administered Zithromac Tablets 600mg.
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | 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) | |||
| 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. | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Case-Only Time Perspective: Retrospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Probability Sample | |||
| Study Population | The subjects whom an investigator involving A0661097 prescribes the Azithromycin Tablets 600mg (Zithromac Tablets 600mg). | |||
| Condition | HIV Infection | |||
| Intervention | 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. Other Name: Zithromac, Zithromax, Azithromycin | |||
| Study Groups/Cohorts | Azithromycin
Patients taking Azithromycin. Intervention: Drug: Azithromycin | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Completed | |||
| Actual Enrollment | 476 | |||
| Original Estimated Enrollment | 500 | |||
| Actual Study Completion Date | March 2012 | |||
| Actual Primary Completion Date | March 2012 (Final data collection date for primary outcome measure) | |||
| 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. | |||
| Sex/Gender |
| |||
| Ages | Child, Adult, Older Adult | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT01227395 | |||
| Other Study ID Numbers | A0661097 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Altmarc Inc. | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | April 2013 | |||