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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00823966
Recruitment Status : Completed
First Posted : January 16, 2009
Results First Posted : July 5, 2010
Last Update Posted : July 5, 2010
Information provided by:

Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: HIV-1 Infection
Intervention: Drug: Rescriptor

  Participant Flow

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Delavirdine Mesilate 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-human immunodeficiency virus (HIV) drugs."

Baseline Measures
   Delavirdine Mesilate 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   3 
>=65 years   0 
[Units: Participants]
Female   0 
Male   3 
Region of Enrollment 
[Units: Participants]
Japan   3 

  Outcome Measures

1.  Primary:   Number of Participants Who Reported Unlisted Adverse Drug Reaction.   [ Time Frame: One Year ]

2.  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).   [ Time Frame: One year ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
There is not enough data to analyze on the efficacy and safety of delavirdine mesylate in the 3 subjects with HIV infection assessed during this study.

  More Information