Safety And Efficacy Of Rescriptor In Patients For Human Immunodeficiency Virus (HIV) Patients
NCT00823966
Last updated date
ABOUT THIS STUDY
The objective of this surveillance is to collect information about 1) adverse drug reaction
not expected from the Local Product Document (LPD) (unlisted 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.
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 Rescriptor® 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 Rescriptor®.
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HIV-1 InfectionSafety And Efficacy Of Rescriptor In Patients For Human Immunodeficiency Virus (HIV) Patients
NCT00823966
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Safety And Efficacy Of Rescriptor In Patients For Human Immunodeficiency Virus (HIV) Patients | |||
| Official Title | Drug Use Investigation For Rescriptor (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 Local Product Document (LPD) (unlisted 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 Rescriptor® 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: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Probability Sample | |||
| Study Population | The patients whom an investigator involving A4351010 prescribes the Delavirdine Mesilate(Rescriptor). | |||
| Condition | HIV-1 Infection | |||
| Intervention | Drug: Rescriptor
RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-HIV drugs." Other Name: Rescripter | |||
| Study Groups/Cohorts | Delavirdine Mesilate
Patients administered. Intervention: Drug: Rescriptor | |||
| 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 | 3 | |||
| Original Estimated Enrollment | Same as current | |||
| Actual Study Completion Date | March 2009 | |||
| Actual Primary Completion Date | March 2009 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria: Patients need to be administered Rescriptor® in order to be enrolled in the surveillance. Exclusion Criteria: Patients not administered Rescriptor®. | |||
| 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 | NCT00823966 | |||
| Other Study ID Numbers | A4351010 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | June 2010 | |||