Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

"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
None.

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  
Number of Participants  
[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 ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information