"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
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Time Frame No text entered.
Additional Description No text entered.

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

Serious Adverse Events
    Atazanavir     Fosamprenavir  
Total, serious adverse events      
# participants affected / at risk     9/39 (23.08%)     6/37 (16.22%)  
Blood and lymphatic system disorders      
Anemia    
# participants affected / at risk     0/39 (0.00%)     1/37 (2.70%)  
# events     0     2  
Gastrointestinal disorders      
Left perineal abscess    
# participants affected / at risk     1/39 (2.56%)     0/0 (0.00%)  
# events     1     0  
Abdominal Pain    
# participants affected / at risk     1/39 (2.56%)     0/37 (0.00%)  
# events     1     0  
General disorders      
death    
# participants affected / at risk     3/39 (7.69%)     2/37 (5.41%)  
# events     3     2  
Infections and infestations      
Cryptococal meningitis    
# participants affected / at risk     0/39 (0.00%)     1/37 (2.70%)  
# events     0     1  
Nervous system disorders      
Seizure Disorder    
# participants affected / at risk     1/39 (2.56%)     0/37 (0.00%)  
# events     5     0  
Intracraneal Hypertension    
# participants affected / at risk     1/39 (2.56%)     0/37 (0.00%)  
# events     1     0  
Reproductive system and breast disorders      
Rupture hemorrhagic cyst    
# participants affected / at risk     0/39 (0.00%)     1/37 (2.70%)  
# events     0     1  
Respiratory, thoracic and mediastinal disorders      
Pneumonia    
# participants affected / at risk     1/39 (2.56%)     1/37 (2.70%)  
# events     1     1  
Skin and subcutaneous tissue disorders      
Steven's Johnson Syndrome    
# participants affected / at risk     1/39 (2.56%)     0/37 (0.00%)  
# events     1     0  
Events were collected by systematic assessment




  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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Roberto C. Arduino, Professor of Medicine
Organization: The University of Texas Health Science Center at Houston
phone: 713-500-6731
e-mail: roberto.c.arduino@uth.tmc.edu


Publications of Results:
Holmes A, Lucke J, Maghidman S, Fernandez-Bussy S, Barnett B, Arduino R. Tenofovir associated nephrotoxicity is dose-dependent ritonavir administration a co-factor? XVI International AIDS Conference. Toronto, Canada. August 13-18, 2006. Abstract TUPE0085.
Bell TK, Holmes A, McCormack OE, Barnett BJ, Arduino RC. Changing Genotypic Resistance Patterns and Demographics of Antiretroviral-Naïve HIV Patients in Houston: 1999-2006. 44th Annual Meeting of the Infectious Diseases Society of America (IDSA). Toronto, Canada. October 12-15, 2006. Abstract 975.
Holmes A, Bell T, Barnett B, Arduino R. Emerging resistance mutations in once-daily ritonavir-boosted protease inhibitor-containing antiretroviral regimens. 44th Annual Meeting of the Infectious Diseases Society of America (IDSA). Toronto, Canada. October 12-15, 2006. Abstract 973.

Other Publications:


Responsible Party: Roberto Arduino, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00242216     History of Changes
Other Study ID Numbers: HSC-MS-03-315
Study First Received: October 18, 2005
Results First Received: May 2, 2013
Last Updated: December 12, 2013
Health Authority: United States: Institutional Review Board