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)

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. Identifier: NCT00931801
Recruitment Status : Completed
First Posted : July 2, 2009
Results First Posted : March 11, 2013
Last Update Posted : July 21, 2017
Bristol-Myers Squibb
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Community Research Initiative of New England

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

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
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

  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 ]

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

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
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  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

Responsible Party: Community Research Initiative of New England 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