We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

BATAR: Individuals Currently Taking Boosted Atazanavir as Part of an HIV Treatment Regimen Will be Evaluated to See if Substituting Raltegravir for Nucleoside Transcriptase Inhibitors Will be Safe and Well Tolerated. (BATAR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00931801
First Posted: July 2, 2009
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Bristol-Myers Squibb
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Community Research Initiative of New England
Results First Submitted: February 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV
Interventions: Drug: atazanavir/raltegravir
Drug: atazanavir/tenofovir/emtricitabine

  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
Recruitment was initiated on 15 APR 2010 and enrolled subjects through 31 JAN 2011. Recruitment and screening took place at 10 participating sites (9 medical clinics and 1 clinical research organization). 43 subjects were enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were 7 participants that did not meet eligibility criteria (either due to disallowed concomitant medication use or safety labs outside of the required parameters). 2 of those 7 subjects re-screened at a later date and were confirmed eligible. 2 subjects withdrew consent after the screening visit but prior to starting the assigned treatment.

Reporting Groups
  Description
Control Arm atazanavir/tenofovir/emtricitabine : Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
Intervention Arm No.1 atazanavir/raltegravir: switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
Intervention Arm No.2 atazanavir/raltegravir: switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily

Participant Flow:   Overall Study
    Control Arm   Intervention Arm No.1   Intervention Arm No.2
STARTED   14   15   14 
COMPLETED   13   14   10 
NOT COMPLETED   1   1   4 
Adverse Event                0                0                1 
Lost to Follow-up                0                1                0 
Withdrawal by Subject                1                0                0 
Confirmed Virologic Failure                0                0                3 



  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
Control Arm atazanavir/tenofovir/emtricitabine : Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
Intervention Arm No.1 atazanavir/raltegravir: switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
Intervention Arm No.2 atazanavir/raltegravir: switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
Total Total of all reporting groups

Baseline Measures
   Control Arm   Intervention Arm No.1   Intervention Arm No.2   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   15   14   43 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.5  (11.6)   47.6  (11.5)   46.6  (6.6)   45.9  (10.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      2  14.3%      2  13.3%      1   7.1%      5  11.6% 
Male      12  85.7%      13  86.7%      13  92.9%      38  88.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      6  42.9%      2  13.3%      5  35.7%      13  30.2% 
Not Hispanic or Latino      8  57.1%      13  86.7%      9  64.3%      30  69.8% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      1   7.1%      0   0.0%      0   0.0%      1   2.3% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      3  21.4%      3  20.0%      3  21.4%      9  20.9% 
White      9  64.3%      12  80.0%      11  78.6%      32  74.4% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1   7.1%      0   0.0%      0   0.0%      1   2.3% 
Region of Enrollment 
[Units: Participants]
       
United States   14   15   14   43 
Mean CD4 
[Units: Cells/mm3]
Mean (Standard Deviation)
 544.6  (197.7)   518.5  (198.9)   533.9  (198.3)   532.0  (193.8) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maintenance of Virologic Suppression   [ Time Frame: 48 weeks ]

2.  Secondary:   The Difference in CD4 From Baseline to Week 48   [ Time Frame: Baseline and Week 48 ]

3.  Secondary:   The Change in Adherence to Study Treatment Arm From Baseline to Week 48   [ Time Frame: Baseline and Week 48 ]
  Hide Outcome Measure 3

Measure Type Secondary
Measure Title The Change in Adherence to Study Treatment Arm From Baseline to Week 48
Measure Description Adherence to study treatment reported as the percentage of doses of the prescribed treatment arm regimen taken, described by each subject through recall of dosing in the three days prior to the visit Baseline and Week 48 vistis. The change in adherence is reflected as the difference of the mean percentage of adherence per arm between Baseline and Week 48 visits.
Time Frame Baseline and Week 48  

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.
Values included for all enrolled participants excluding participants with confirmed virologic failure or those missing values due to early withdrawal, loss to follow-up or other error.

Reporting Groups
  Description
Control Arm Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
Intervention Arm No.1 switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
Intervention Arm No.2 switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
Total All study arms combined

Measured Values
   Control Arm   Intervention Arm No.1   Intervention Arm No.2   Total 
Participants Analyzed 
[Units: Participants]
 12   13   10   35 
The Change in Adherence to Study Treatment Arm From Baseline to Week 48 
[Units: Percentage of prescribed doses]
Mean (Standard Deviation)
       
3 Day Adherence Recall at Baseline   100  (0)   97.5  (9.2)   96.7  (10.4)   98.1  (7.8) 
3 Day Adherence Recall at Week 48   100  (0)   97.5  (9.2)   95.0  (15.8)   97.6  (10) 
Change in 3 Day Adherence Recall   0  (0)   0  (13.5)   -1.7  (19.9)   -0.5  (13) 

No statistical analysis provided for The Change in Adherence to Study Treatment Arm From Baseline to Week 48



4.  Secondary:   Change in Quality of Life From Baseline to 48 Weeks of Study Treatment   [ Time Frame: baseline and 48 weeks ]


  Serious Adverse Events


  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
No text entered.


  More Information
  Hide More Information

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


Results Point of Contact:  
Name/Title: Calvin J. Cohen MD, MSc, Director of Research
Organization: Community Research Initiative of New England
phone: 617-502-1700
e-mail: ccohen@crine.org



Responsible Party: Community Research Initiative of New England
ClinicalTrials.gov Identifier: NCT00931801     History of Changes
Other Study ID Numbers: 09-102
First Submitted: June 30, 2009
First Posted: July 2, 2009
Results First Submitted: February 5, 2013
Results First Posted: March 11, 2013
Last Update Posted: July 21, 2017