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"The Once A Day Protease Inhibitor Regimens"

This study has been completed.
Information provided by (Responsible Party):
Roberto Arduino, The University of Texas Health Science Center, Houston Identifier:
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
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
Atazanavir No text entered.
Fosamprenavir No text entered.
Total Total of all reporting groups

Baseline Measures
    Atazanavir   Fosamprenavir   Total
Overall Participants 
[units: participants]
 39   37   76 
[units: participants]
<=18 years   0   0   0 
Between 18 and 65 years   38   33   71 
>=65 years   1   4   5 
[units: years]
Mean (Standard Deviation)
 48  (9.7)   48  (10)   48  (10) 
[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 ]

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

  Serious Adverse Events

  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5  

Reporting Groups
Atazanavir No text entered.
Fosamprenavir No text entered.

Other Adverse Events
    Atazanavir   Fosamprenavir
Total, other (not including serious) adverse events     
# participants affected / at risk   9/39 (23.08%)   0/37 (0.00%) 
Gastrointestinal disorders     
# participants affected / at risk   7/39 (17.95%)   0/37 (0.00%) 
# events   7   0 
Hepatobiliary disorders     
Increased LFTs †     
# participants affected / at risk   2/39 (5.13%)   0/37 (0.00%) 
# events   2   0 
Events were collected by systematic assessment

  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.

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