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.

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Cal Cohen, Community Research Initiative of New England
ClinicalTrials.gov Identifier:
NCT00931801
First received: June 30, 2009
Last updated: March 14, 2013
Last verified: March 2013
Results First Received: February 5, 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
Interventions: Drug: atazanavir/raltegravir
Drug: atazanavir/tenofovir/emtricitabine

  Participant Flow


  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  
Number of Participants  
[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  
Gender  
[units: participants]
       
Female     2     2     1     5  
Male     12     13     13     38  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     6     2     5     13  
Not Hispanic or Latino     8     13     9     30  
Unknown or Not Reported     0     0     0     0  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     0     0  
Asian     1     0     0     1  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     3     3     3     9  
White     9     12     11     32  
More than one race     0     0     0     0  
Unknown or Not Reported     1     0     0     1  
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 ]

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


No publications provided


Responsible Party: Cal Cohen, Community Research Initiative of New England
ClinicalTrials.gov Identifier: NCT00931801     History of Changes
Other Study ID Numbers: 09-102
Study First Received: June 30, 2009
Results First Received: February 5, 2013
Last Updated: March 14, 2013
Health Authority: United States: Food and Drug Administration