Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

"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
History of Changes
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
  Hide Participant Flow

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
  Hide 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
  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
  Show All Outcome Measures

1.  Primary:   Proportion of Patient With Viral Load Less Than 400 Copies/mL   [ Time Frame: 24 weeks ]
  Show Outcome Measure 1

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


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  Limitations and Caveats
  Hide 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
High porportion of subject did not complete the study.


  More Information
  Show More Information