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

Completed

• Conditions: HIV-1 Infection
• Interventions: Drug: Rescriptor

• Registration Number: NCT00823966
• Lead Sponsor: Pfizer

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 Timeline

• Study Start: 2003-12
• Study First Submitted: 2009-01-14
• Study First Submitted QC: 2009-01-15
• Study First Posted: 2009-01-16
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Results First Submitted: 2010-03-04
• Status Verified: 2010-06
• Results First Submitted QC: 2010-06-02
• Last Update Submitted: 2010-06-02
• Results First Posted: 2010-07-05
• Last Update Posted: 2010-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

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

Exclusion Criteria

Patients not administered Rescriptor®.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Delavirdine Mesilate	Rescriptor	Patients administered.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Reported Unlisted Adverse Drug Reaction.	One Year	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).	One year	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.