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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00823966
First received: January 14, 2009
Last updated: June 2, 2010
Last verified: June 2010
Results First Received: March 4, 2010  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: HIV-1 Infection
Intervention: Drug: Rescriptor

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
08 December 2003 to 31 March 2009, a total of two centers in Japan

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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."

Participant Flow:   Overall Study
    Delavirdine Mesilate  
STARTED     3  
COMPLETED     3  
NOT COMPLETED     0  



  Baseline Characteristics
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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
  Description
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  
Number of Participants  
[units: participants]
  3  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     3  
>=65 years     0  
Gender  
[units: participants]
 
Female     0  
Male     3  
Region of Enrollment  
[units: participants]
 
Japan     3  



  Outcome Measures
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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
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Time Frame One year
Additional Description No text entered.

Reporting Groups
  Description
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."

Serious Adverse Events
    Delavirdine Mesilate  
Total, serious adverse events    
# participants affected / at risk     2/3 (66.67%)  
Infections and infestations    
Pneumocystis jiroveci pneumonia † 1  
# participants affected / at risk     1/3 (33.33%)  
# events     1  
Respiratory, thoracic and mediastinal disorders    
hypoxia † 1  
# participants affected / at risk     1/3 (33.33%)  
# events     1  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA J12.0




  Other Adverse Events


  Limitations and Caveats
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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.


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