Safety And Efficacy Of Maraviroc In Patients For HIV Patients (Regulatory Post Marketing Commitment Plan)
NCT00864474
Last updated date
ABOUT THIS STUDY
The objective of this surveillance is to collect information about 1) adverse drug reaction
not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug
reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy
of this drug.
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.
CCR5-tropic HIV-1 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 CELSENTRI® Tablets 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 CELSENTRI® Tablets.
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CCR5-tropic HIV-1 InfectionSafety And Efficacy Of Maraviroc In Patients For HIV Patients (Regulatory Post Marketing Commitment Plan)
NCT00864474
ALL GENDERS
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Advanced Information
| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title | Safety And Efficacy Of Maraviroc In Patients For HIV Patients (Regulatory Post Marketing Commitment Plan) | ||||||
| Official Title | DRUG USE INVESTIGATION FOR HIV INFECTION PATIENTS OF MARAVIROC (REGULATORY POST MARKETING COMMITMENT PLAN). | ||||||
| Brief Summary | The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug. | ||||||
| Detailed Description | All the patients whom an investigator prescribes the first CELSENTRI® Tablets 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 patients whom an investigator involving A4001093 prescribes the Maraviroc Tablets (CELSENTRI® Tablets). | ||||||
| Condition | CCR5-tropic HIV-1 Infection | ||||||
| Intervention | Drug: CELSENTRI® Tablets
CELSENTRI ® Tablets 150mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". Other Name: CELSENTRI® Tablets, maraviroc, Selzentry | ||||||
| Study Groups/Cohorts | Maraviroc Tablets
Patients administered. Intervention: Drug: CELSENTRI® Tablets | ||||||
| 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 | 68 | ||||||
| Original Estimated Enrollment | 50 | ||||||
| Actual Study Completion Date | December 24, 2018 | ||||||
| Actual Primary Completion Date | December 24, 2018 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria | Inclusion Criteria: Patients need to be administered CELSENTRI® Tablets in order to be enrolled in the surveillance. Exclusion Criteria: Patients not administered CELSENTRI® Tablets. | ||||||
| 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 | NCT00864474 | ||||||
| Other Study ID Numbers | A4001093 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
| ||||||
| IPD Sharing Statement |
| ||||||
| Responsible Party | ViiV Healthcare | ||||||
| Study Sponsor | ViiV Healthcare | ||||||
| Collaborators | Pfizer | ||||||
| Investigators |
| ||||||
| PRS Account | ViiV Healthcare | ||||||
| Verification Date | December 2019 | ||||||