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"The Once A Day Protease Inhibitor Regimens"

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roberto Arduino, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00242216
First received: October 18, 2005
Last updated: December 12, 2013
Last verified: December 2013
Results First Received: May 2, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: ritonavir-boosted atazanavir
Drug: ritonavir-boosted fosamprenavir

  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
Patients enrolled at a county clinic

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
Atazanavir Atazanavir/ritonavir (300mg/100mg) once daily
Fosamprenavir Fosamprenavir/ritonavir (1400mg/100mg) once daily

Participant Flow:   Overall Study
    Atazanavir   Fosamprenavir
STARTED   39   37 
COMPLETED   21   15 
NOT COMPLETED   18   22 
Lost to Follow-up                12                17 
Death                4                2 
Lack of Efficacy                1                2 
no medicaiton dispensed                1                1 



  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
Atazanavir No text entered.
Fosamprenavir No text entered.
Total Total of all reporting groups

Baseline Measures
   Atazanavir   Fosamprenavir   Total 
Overall Participants Analyzed 
[Units: Participants]
 39   37   76 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   38   33   71 
>=65 years   1   4   5 
Age 
[Units: Years]
Mean (Standard Deviation)
 48  (9.7)   48  (10)   48  (10) 
Gender 
[Units: Participants]
     
Female   11   9   20 
Male   28   28   56 
Region of Enrollment 
[Units: Participants]
     
United States   39   37   76 


  Outcome Measures
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1.  Primary:   Proportion of Patient With Viral Load Less Than 400 Copies/mL   [ Time Frame: 24 weeks ]
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Measure Type Primary
Measure Title Proportion of Patient With Viral Load Less Than 400 Copies/mL
Measure Description No text entered.
Time Frame 24 weeks  
Safety Issue No  

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
Atazanavir No text entered.
Fosamprenavir No text entered.

Measured Values
   Atazanavir   Fosamprenavir 
Participants Analyzed 
[Units: Participants]
 18   15 
Proportion of Patient With Viral Load Less Than 400 Copies/mL 
[Units: Percentage]
 89   73 

No statistical analysis provided for Proportion of Patient With Viral Load Less Than 400 Copies/mL



2.  Secondary:   CD4 Cell Count Change From Baseline During Treatment.   [ Time Frame: 24 weeks. ]


  Serious Adverse Events


  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
High porportion of subject did not complete the study.


  More Information