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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00823966
First received: January 14, 2009
Last updated: June 2, 2010
Last verified: June 2010

January 14, 2009
June 2, 2010
December 2003
March 2009   (final data collection date for primary outcome measure)
  • Number of Participants Who Reported Unlisted Adverse Drug Reaction. [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
    Adverse drug reaction that is not listed in the Japanese Package Insert(Same as Local product Document).
  • Number of Participants Who Improved in Number of HIV- Ribonucleic Acid (RNA) Copies, Cluster of Differentiation 4(CD4) Count, and Not Progress in HIV Classification: Centers for Disease Control and Prevention Clinical Category (CDC Category). [ Time Frame: One year ] [ Designated as safety issue: No ]

    Improvement of number of HIV-RNA copies; Improvement is measured by general evaluation of decrease in HIV-RNA copies.

    Improvement of CD4 counts; Improvement is measured by general evaluation of increase in CD4 counts.

    Not progress in HIV classification (severity of CDC category); Subjects were classified based on the severity of CDC category as mild (Category A), moderate (Category B), and severe (Category C). No change categories from Category A to Category B / Category C, or from Category B to Category C in CDC category.

  • The incidence of adverse drug reactions in this surveillance. [ Time Frame: 8.5 Years (MAX) ] [ Designated as safety issue: Yes ]
  • Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). [ Time Frame: 8.5 Years (MAX) ] [ Designated as safety issue: Yes ]
  • Factors considered to affect the safety and/or efficacy of this drug. [ Time Frame: 8.5 Years (MAX) ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00823966 on ClinicalTrials.gov Archive Site
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Safety And Efficacy Of Rescriptor In Patients For Human Immunodeficiency Virus (HIV) Patients
Drug Use Investigation For Rescriptor (Regulatory Post Marketing Commitment Plan)

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

The patients whom an investigator involving A4351010 prescribes the Delavirdine Mesilate(Rescriptor).

HIV-1 Infection
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
Delavirdine Mesilate
Patients administered.
Intervention: Drug: Rescriptor
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3
March 2009
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

Patients need to be administered Rescriptor® in order to be enrolled in the surveillance.

Exclusion Criteria:

Patients not administered Rescriptor®.

Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00823966
A4351010
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP