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

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.

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Key information

Conditions

HIV-1 Infection

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Patients not administered Rescriptor®.

Treatment and study plan

Rescriptor

Drug

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 names: Rescripter

Primary outcomes

Number of Participants Who Reported Unlisted Adverse Drug Reaction.

Time frame: 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).

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start: 2003
Primary completion: 2009
Study completion: 2009
First posted: Jan 16, 2009
Registry last updated: Jul 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed