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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
Enrollment 50

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Switch Continuation
Hide Arm/Group Description

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

atazanavir: switch to unboosted atazanavir 400 mg daily

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

Period Title: Overall Study
Started 25 25
Completed 23 19
Not Completed 2 6
Arm/Group Title Switch Continuation Total
Hide Arm/Group Description Switch to atazanavir 400 mg daily Remain on atazanavir/ritonavir 300mg/100 mg daily Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
48
(42 to 52)
46
(39 to 53)
47
(40 to 53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
2
   8.0%
2
   8.0%
4
   8.0%
Male
23
  92.0%
23
  92.0%
46
  92.0%
1.Primary Outcome
Title Proportions of Subjects Experiencing Virologic Failure by Randomized Treatment Arm
Hide Description For the purposes of the study, virologic failure is defined as either regimen change for any reason, or plasma viral load >400 copies/mL on 2 consecutive measurements >2 weeks apart.
Time Frame at or before 48 weeks.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Switch Continuation
Hide Arm/Group Description:
Switch to atazanavir 400 mg daily
Remain on atazanavir/ritonavir 300mg/100mg daily
Overall Number of Participants Analyzed 25 25
Measure Type: Count of Participants
Unit of Measure: Participants
2
   8.0%
6
  24.0%
2.Secondary Outcome
Title Proportions of Subjects in Each Randomized Treatment Arm With Atazanavir Trough Levels Below 150ng/mL
Hide Description Therapeutic drug monitoring (TDM) to determine atazanavir trough plasma level will be performed once on all subjects at 4-8 weeks
Time Frame 1 month (4-8 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Switch Continuation
Hide Arm/Group Description:
Switch to atazanavir 400 mg daily
Remain on atazanavir/ritonavir 300mg/100mg
Overall Number of Participants Analyzed 24 12
Measure Type: Count of Participants
Unit of Measure: Participants
14
  58.3%
3
  25.0%
3.Secondary Outcome
Title Proportion of Subjects Experiencing Virologic Failure by Results of 1-month TDM
Hide Description For the purposes of the study, virologic failure is defined as either regimen change for any reason, or plasma viral load >400 copies/mL on 2 consecutive measurements >2 weeks apart. Comparison will be made between subjects with 1-month (4-8 week) on-study atazanavir trough levels <150ng/mL and those with 1-month (4-8 week) on-study atazanavir trough levels >150ng/mL.
Time Frame at or before 48 weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Proportions of Subjects Experiencing Virologic Failure by Randomized Treatment Arm
Hide Description For the purposes of the study, virologic failure is defined as either regimen change for any reason, or plasma viral load >400 copies/mL on 2 consecutive measurements >2 weeks apart.
Time Frame at or before 24 weeks.
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Proportion of Subjects Experiencing Virologic Failure by Results of 1-month TDM
Hide Description For the purposes of the study, virologic failure is defined as either regimen change for any reason, or plasma viral load >400 copies/mL on 2 consecutive measurements >2 weeks apart. Comparison will be made between subjects with 1-month (4-8 week) on-study atazanavir trough levels <150ng/mL and those with 1-month (4-8 week) on-study atazanavir trough levels >150ng/mL.
Time Frame at or before 24 weeks
Outcome Measure Data Not Reported
6.Secondary Outcome
Title CD4 Cell Count Changes (Absolute and Fraction)
Hide Description Comparison will be made between randomized treatment arms.
Time Frame 24 and 48 weeks
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Safety (Clinical and Laboratory Adverse Events)
Hide Description Serious adverse events and discontinuations will be compared between randomized treatment arms
Time Frame 24 and 48 weeks
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Total Serum Bilirubin Levels
Hide Description Comparison will be made between randomized treatment arms.
Time Frame 24 and 48 weeks
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Metabolic Parameters
Hide Description Comparison will be made between randomized treatment arms with respect to changes in fasting lipids and glucose, highly sensitive C-reactive protein [hsCRP], and apolipoprotein [apo]B, and proportions of subjects developing abnormalities or crossing predefined limits (e.g. NCEP thresholds for lipids)
Time Frame 24 and 48 weeks
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Quality of Life as Assessed by MOS-HIV
Hide Description Changes in MOS-HIV scores from baseline will be compared between randomized treatment arms.
Time Frame 24 and 48 weeks
Outcome Measure Data Not Reported
Time Frame 48 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Switch Continuation
Hide Arm/Group Description Switch to atazanavir 400 mg daily Remain on atazanavir/ritonavir 300 mg/100 mg daily
All-Cause Mortality
Switch Continuation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Switch Continuation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Switch Continuation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   3/25 (12.00%) 
Gastrointestinal disorders     
diarrhea   0/25 (0.00%)  1/25 (4.00%) 
Renal and urinary disorders     
renal toxicity   0/25 (0.00%)  2/25 (8.00%) 
Indicates events were collected by systematic assessment
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
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