Safety And Efficacy Of Rescriptor In Patients For Human Immunodeficiency Virus (HIV) Patients
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|ClinicalTrials.gov Identifier: NCT00823966|
Recruitment Status : Completed
First Posted : January 16, 2009
Results First Posted : July 5, 2010
Last Update Posted : July 5, 2010
|Condition or disease||Intervention/treatment||Phase|
|HIV-1 Infection||Drug: Rescriptor||Phase 4|
|Study Type :||Observational|
|Actual Enrollment :||3 participants|
|Official Title:||Drug Use Investigation For Rescriptor (Regulatory Post Marketing Commitment Plan)|
|Study Start Date :||December 2003|
|Primary Completion Date :||March 2009|
|Study Completion Date :||March 2009|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00823966
|Study Director:||Pfizer CT.gov Call Center||Pfizer|