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Switch to Unboosted Atazanavir With Tenofovir Study (SUAT)

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ClinicalTrials.gov Identifier: NCT01351740
Recruitment Status : Completed
First Posted : May 11, 2011
Results First Posted : July 30, 2018
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Marianne Harris, MD, University of British Columbia

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV Infection
Interventions: Drug: atazanavir
Drug: atazanavir/ritonavir

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Switch

switch to unboosted atazanavir 400mg daily with the same nucleoside (NRTI) backbone

atazanavir: switch to unboosted atazanavir 400 mg daily

Continuation

continue on current regimen of atazanavir/ritonavir 300mg/100mg with the same nucleoside (NRTI) backbone

atazanavir/ritonavir: Continue current regimen of atazanavir 300 mg/ ritonavir 100 mg daily


Participant Flow:   Overall Study
    Switch   Continuation
STARTED   25   25 
COMPLETED   23   19 
NOT COMPLETED   2   6 



  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
Switch Switch to atazanavir 400 mg daily
Continuation Remain on atazanavir/ritonavir 300mg/100 mg daily
Total Total of all reporting groups

Baseline Measures
   Switch   Continuation   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   25   50 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 48 
 (42 to 52) 
 46 
 (39 to 53) 
 47 
 (40 to 53) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2   8.0%      2   8.0%      4   8.0% 
Male      23  92.0%      23  92.0%      46  92.0% 


  Outcome Measures

1.  Primary:   Proportions of Subjects Experiencing Virologic Failure by Randomized Treatment Arm   [ Time Frame: at or before 48 weeks. ]

2.  Secondary:   Proportions of Subjects in Each Randomized Treatment Arm With Atazanavir Trough Levels Below 150ng/mL   [ Time Frame: 1 month (4-8 weeks) ]

3.  Secondary:   Proportion of Subjects Experiencing Virologic Failure by Results of 1-month TDM   [ Time Frame: at or before 48 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Proportions of Subjects Experiencing Virologic Failure by Randomized Treatment Arm   [ Time Frame: at or before 24 weeks. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Proportion of Subjects Experiencing Virologic Failure by Results of 1-month TDM   [ Time Frame: at or before 24 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   CD4 Cell Count Changes (Absolute and Fraction)   [ Time Frame: 24 and 48 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Safety (Clinical and Laboratory Adverse Events)   [ Time Frame: 24 and 48 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Secondary:   Total Serum Bilirubin Levels   [ Time Frame: 24 and 48 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Secondary:   Metabolic Parameters   [ Time Frame: 24 and 48 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

10.  Secondary:   Quality of Life as Assessed by MOS-HIV   [ Time Frame: 24 and 48 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Marianne Harris
Organization: British Columbia Centre for Excellence in HIV/AIDS
phone: 1-604-806-8771
e-mail: mharris@cfenet.ubc.ca


Publications of Results:

Responsible Party: Marianne Harris, MD, University of British Columbia
ClinicalTrials.gov Identifier: NCT01351740     History of Changes
Other Study ID Numbers: H10-03255
H10-03255 ( Other Identifier: UBC/Providence Health Care REB )
First Submitted: May 9, 2011
First Posted: May 11, 2011
Results First Submitted: October 24, 2017
Results First Posted: July 30, 2018
Last Update Posted: July 30, 2018