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

HIV-1 Infection Clinical Trial

Official title:

Drug Use Investigation For Rescriptor (Regulatory Post Marketing Commitment Plan)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00823966
• Other study ID #: A4351010
• Status: Completed
• Phase: Phase 4
• First received: January 14, 2009
• Last updated: June 2, 2010
• Start date: December 2003
• Est. completion date: March 2009

Study information

• Verified date: June 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency (PMDA)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Patients not administered Rescriptor®.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• 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."

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Reported Unlisted Adverse Drug Reaction.	Adverse drug reaction that is not listed in the Japanese Package Insert(Same as Local product Document).	One Year	Yes
Primary	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).	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.	One year	No

External Links

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