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
  Purpose

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.


Condition Intervention Phase
HIV-1 Infection
Drug: Rescriptor
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Drug Use Investigation For Rescriptor (Regulatory Post Marketing Commitment Plan)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.



Enrollment: 3
Study Start Date: December 2003
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Delavirdine Mesilate
Patients administered.
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients not administered Rescriptor®.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823966

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00823966     History of Changes
Other Study ID Numbers: A4351010
Study First Received: January 14, 2009
Results First Received: March 4, 2010
Last Updated: June 2, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency (PMDA)

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Delavirdine
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014