Safety And Efficacy Of Rescriptor In Patients For Human Immunodeficiency Virus (HIV) Patients

NCT00823966

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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
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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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
 (submitted: January 15, 2009)
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
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2010