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
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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
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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
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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
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Time Frame 48 Weeks
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

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

Other Adverse Events
    Control Arm     Intervention Arm No.1     Intervention Arm No.2     Total  
Total, other (not including serious) adverse events          
# participants affected / at risk     9/14     13/15     13/14     35/43  
Blood and lymphatic system disorders          
hypertophy of tonsils        
# participants affected / at risk     1/14 (7.14%)     0/15 (0.00%)     0/14 (0.00%)     1/43 (2.33%)  
# events     1     0     0     1  
lymphadenopathy        
# participants affected / at risk     0/14 (0.00%)     1/15 (6.67%)     1/14 (7.14%)     2/43 (4.65%)  
# events     0     1     1     2  
Cardiac disorders          
chest pain        
# participants affected / at risk     1/14 (7.14%)     0/15 (0.00%)     0/14 (0.00%)     1/43 (2.33%)  
# events     1     0     0     1  
ECG changes        
# participants affected / at risk     1/14 (7.14%)     0/15 (0.00%)     0/14 (0.00%)     1/43 (2.33%)  
# events     1     0     0     1  
hypertension        
# participants affected / at risk     0/14 (0.00%)     1/15 (6.67%)     1/14 (7.14%)     2/43 (4.65%)  
# events     0     1     1     2  
palpitations without chest pain        
# participants affected / at risk     0/14 (0.00%)     0/15 (0.00%)     1/14 (7.14%)     1/43 (2.33%)  
# events     0     0     1     1  
Ear and labyrinth disorders          
eustacian tube dysfunction        
# participants affected / at risk     0/14 (0.00%)     0/15 (0.00%)     1/14 (7.14%)     1/43 (2.33%)  
# events     0     0     1     1  
Endocrine disorders          
hypogonadism        
# participants affected / at risk     0/14 (0.00%)     0/15 (0.00%)     1/14 (7.14%)     1/43 (2.33%)  
# events     0     0     1     1  
Eye disorders          
visual disturbance        
# participants affected / at risk     0/14 (0.00%)     1/15 (6.67%)     0/14 (0.00%)     1/43 (2.33%)  
# events     0     1     0     1  
vitreous detachment        
# participants affected / at risk     0/14 (0.00%)     1/15 (6.67%)     0/14 (0.00%)     1/43 (2.33%)  
# events     0     1     0     1  
Gastrointestinal disorders          
abdominal pain        
# participants affected / at risk     1/14 (7.14%)     0/15 (0.00%)     0/14 (0.00%)     1/43 (2.33%)  
# events     1     0     0     1  
apthous ulcer        
# participants affected / at risk     1/14 (7.14%)     0/15 (0.00%)     0/14 (0.00%)     1/43 (2.33%)  
# events     1     0     0     1  
changes to bowel movements        
# participants affected / at risk     0/14 (0.00%)     0/15 (0.00%)     1/14 (7.14%)     1/43 (2.33%)  
# events     0     0     1     1  
constipation        
# participants affected / at risk     1/14 (7.14%)     0/15 (0.00%)     0/14 (0.00%)     1/43 (2.33%)  
# events     1     0     0     1  
dental pain        
# participants affected / at risk     1/14 (7.14%)     0/15 (0.00%)     0/14 (0.00%)     1/43 (2.33%)  
# events     1     0     0     1  
diarrhea        
# participants affected / at risk     0/14 (0.00%)     3/15 (20.00%)     3/14 (21.43%)     6/43 (13.95%)  
# events     0     3     3     6  
dry throat        
# participants affected / at risk     0/14 (0.00%)     0/15 (0.00%)     1/14 (7.14%)     1/43 (2.33%)  
# events     0     0     1     1  
dyspepsia        
# participants affected / at risk     1/14 (7.14%)     0/15 (0.00%)     0/14 (0.00%)     1/43 (2.33%)  
# events     1     0     0     1  
feeling full upon awakening        
# participants affected / at risk     0/14 (0.00%)     0/15 (0.00%)     1/14 (7.14%)     1/43 (2.33%)  
# events     0     0     1     1  
flatulence        
# participants affected / at risk     0/14 (0.00%)     1/15 (6.67%)     1/14 (7.14%)     2/43 (4.65%)  
# events     0     1     1     2  
gastroesophageal reflux disease        
# participants affected / at risk     0/14 (0.00%)     1/15 (6.67%)     2/14 (14.29%)     3/43 (6.98%)  
# events     0     1     2     3  
GI disturbance        
# participants affected / at risk     0/14 (0.00%)     1/15 (6.67%)     0/14 (0.00%)     1/43 (2.33%)  
# events     0     1     0     1  
gingivitis        
# participants affected / at risk     1/14 (7.14%)     0/15 (0.00%)     0/14 (0.00%)     1/43 (2.33%)  
# events     1     0     0     1  
heart burn        
# participants affected / at risk     0/14 (0.00%)     1/15 (6.67%)     0/14 (0.00%)     1/43 (2.33%)  
# events     0     1     0     1  
nausea        
# participants affected / at risk     0/14 (0.00%)     0/15 (0.00%)     1/14 (7.14%)     1/43 (2.33%)  
# events     0     0     1     1  
Pharyngitis        
# participants affected / at risk     2/14 (14.29%)     1/15 (6.67%)     2/14 (14.29%)     5/43 (11.63%)  
# events     2     1     2     5  
tooth abscess        
# participants affected / at risk     0/14 (0.00%)     1/15 (6.67%)     0/14 (0.00%)     1/43 (2.33%)  
# events     0     1     0     1  
General disorders          
Fatigue        
# participants affected / at risk     1/14 (7.14%)     0/15 (0.00%)     2/14 (14.29%)     3/43 (6.98%)  
# events     1     0     2     3  
Nightsweats        
# participants affected / at risk     0/14 (0.00%)     0/15 (0.00%)     1/14 (7.14%)     1/43 (2.33%)  
# events     0     0     1     1  
Thirst        
# participants affected / at risk     0/14 (0.00%)     0/15 (0.00%)     1/14 (7.14%)     1/43 (2.33%)  
# events     0     0     1     1  
weight gain        
# participants affected / at risk     0/14 (0.00%)     1/15 (6.67%)     0/14 (0.00%)     1/43 (2.33%)  
# events     0     1     0     1  
Infections and infestations          
conjunctivitis        
# participants affected / at risk     0/14 (0.00%)     0/15 (0.00%)     1/14 (7.14%)     1/43 (2.33%)  
# events     0     0     1     1  
Gastroenteritis        
# participants affected / at risk     0/14 (0.00%)     1/15 (6.67%)     0/14 (0.00%)     1/43 (2.33%)  
# events     0     1     0     1  
influenza like illness        
# participants affected / at risk     0/14 (0.00%)     1/15 (6.67%)     1/14 (7.14%)     2/43 (4.65%)  
# events     0     1     1     2  
latent mycobacterium tuberculosis Infection        
# participants affected / at risk     0/14 (0.00%)     1/15 (6.67%)     0/14 (0.00%)     1/43 (2.33%)  
# events     0     1     0     1  
scabies        
# participants affected / at risk     0/14 (0.00%)     1/15 (6.67%)     0/14 (0.00%)     1/43 (2.33%)  
# events     0     1     0     1  
Sinusitis        
# participants affected / at risk     1/14 (7.14%)     0/15 (0.00%)     0/14 (0.00%)     1/43 (2.33%)  
# events     1     0     0     1  
STI        
# participants affected / at risk     1/14 (7.14%)     2/15 (13.33%)     2/14 (14.29%)     5/43 (11.63%)  
# events     1     2     2     5  
Injury, poisoning and procedural complications          
bone fracture        
# participants affected / at risk     0/14 (0.00%)     0/15 (0.00%)     1/14 (7.14%)     1/43 (2.33%)  
# events     0     0     1     1  
facial laceration        
# participants affected / at risk     0/14 (0.00%)     2/15 (13.33%)     0/14 (0.00%)     2/43 (4.65%)  
# events     0     2     0     2  
leg pain        
# participants affected / at risk     0/14 (0.00%)     1/15 (6.67%)     0/14 (0.00%)     1/43 (2.33%)  
# events     0     1     0     1  
Musculoskeletal and connective tissue disorders          
arthralgia        
# participants affected / at risk     0/14 (0.00%)     0/15 (0.00%)     1/14 (7.14%)     1/43 (2.33%)  
# events     0     0     1     1  
gout        
# participants affected / at risk     0/14 (0.00%)     1/15 (6.67%)     0/14 (0.00%)     1/43 (2.33%)  
# events     0     1     0     1  
lower back pain        
# participants affected / at risk     0/14 (0.00%)     0/15 (0.00%)     2/14 (14.29%)     2/43 (4.65%)  
# events     0     0     2     2  
lower extremity ache        
# participants affected / at risk     0/14 (0.00%)     0/15 (0.00%)     1/14 (7.14%)     1/43 (2.33%)  
# events     0     0     1     1  
lower extremity pain        
# participants affected / at risk     0/14 (0.00%)     0/15 (0.00%)     2/14 (14.29%)     2/43 (4.65%)  
# events     0     0     2     2  
neck pain        
# participants affected / at risk     1/14 (7.14%)     0/15 (0.00%)     0/14 (0.00%)     1/43 (2.33%)  
# events     1     0     0     1  
popliteal cyst        
# participants affected / at risk     0/14 (0.00%)     1/15 (6.67%)     0/14 (0.00%)     1/43 (2.33%)  
# events     0     1     0     1  
shoulder pain        
# participants affected / at risk     0/14 (0.00%)     1/15 (6.67%)     1/14 (7.14%)     2/43 (4.65%)  
# events     0     1     1     2  
Nervous system disorders          
Dizziness        
# participants affected / at risk     0/14 (0.00%)     1/15 (6.67%)     1/14 (7.14%)     2/43 (4.65%)  
# events     0     1     1     2  
Headache        
# participants affected / at risk     1/14 (7.14%)     3/15 (20.00%)     2/14 (14.29%)     6/43 (13.95%)  
# events     1     3     2     6  
insomnia        
# participants affected / at risk     0/14 (0.00%)     1/15 (6.67%)     2/14 (14.29%)     3/43 (6.98%)  
# events     0     1     2     3  
light headedness        
# participants affected / at risk     0/14 (0.00%)     1/15 (6.67%)     0/14 (0.00%)     1/43 (2.33%)  
# events     0     1     0     1  
paresthesias        
# participants affected / at risk     0/14 (0.00%)     0/15 (0.00%)     1/14 (7.14%)     1/43 (2.33%)  
# events     0     0     1     1  
vivid dreams        
# participants affected / at risk     0/14 (0.00%)     1/15 (6.67%)     0/14 (0.00%)     1/43 (2.33%)  
# events     0     1     0     1  
Psychiatric disorders          
Anxiety        
# participants affected / at risk     0/14 (0.00%)     1/15 (6.67%)     0/14 (0.00%)     1/43 (2.33%)  
# events     0     1     0     1  
Depression        
# participants affected / at risk     2/14 (14.29%)     1/15 (6.67%)     1/14 (7.14%)     4/43 (9.30%)  
# events     2     1     1     4  
Renal and urinary disorders          
Dysuria        
# participants affected / at risk     1/14 (7.14%)     1/15 (6.67%)     0/14 (0.00%)     2/43 (4.65%)  
# events     1     1     0     2  
Renal Calculus        
# participants affected / at risk     0/14 (0.00%)     1/15 (6.67%)     0/14 (0.00%)     1/43 (2.33%)  
# events     0     1     0     1  
Urinary Tract Infection        
# participants affected / at risk     1/14 (7.14%)     0/15 (0.00%)     0/14 (0.00%)     1/43 (2.33%)  
# events     1     0     0     1  
Reproductive system and breast disorders          
Erectile dysfunction        
# participants affected / at risk     0/14 (0.00%)     0/15 (0.00%)     1/14 (7.14%)     1/43 (2.33%)  
# events     0     0     1     1  
Respiratory, thoracic and mediastinal disorders          
Allergic Rhinitis        
# participants affected / at risk     2/14 (14.29%)     2/15 (13.33%)     0/14 (0.00%)     4/43 (9.30%)  
# events     2     2     0     4  
Bronchitis        
# participants affected / at risk     0/14 (0.00%)     3/15 (20.00%)     1/14 (7.14%)     4/43 (9.30%)  
# events     0     3     2     5  
Cough        
# participants affected / at risk     0/14 (0.00%)     1/15 (6.67%)     0/14 (0.00%)     1/43 (2.33%)  
# events     0     1     0     1  
Sinus Pressure        
# participants affected / at risk     1/14 (7.14%)     0/15 (0.00%)     0/14 (0.00%)     1/43 (2.33%)  
# events     1     0     0     1  
Upper Respiratory Congestion        
# participants affected / at risk     1/14 (7.14%)     0/15 (0.00%)     2/14 (14.29%)     3/43 (6.98%)  
# events     1     0     2     3  
Upper Respiratory Infection        
# participants affected / at risk     0/14 (0.00%)     1/15 (6.67%)     3/14 (21.43%)     4/43 (9.30%)  
# events     0     2     3     5  
Skin and subcutaneous tissue disorders          
Abscess        
# participants affected / at risk     1/14 (7.14%)     1/15 (6.67%)     1/14 (7.14%)     3/43 (6.98%)  
# events     1     2     1     4  
Angular Chelitis        
# participants affected / at risk     0/14 (0.00%)     1/15 (6.67%)     0/14 (0.00%)     1/43 (2.33%)  
# events     0     1     0     1  
Cutaneous Sarcoidosis, worsening        
# participants affected / at risk     0/14 (0.00%)     1/15 (6.67%)     0/14 (0.00%)     1/43 (2.33%)  
# events     0     1     0     1  
Dermatitis        
# participants affected / at risk     2/14 (14.29%)     0/15 (0.00%)     0/14 (0.00%)     2/43 (4.65%)  
# events     2     0     0     2  
Dry Skin        
# participants affected / at risk     0/14 (0.00%)     0/15 (0.00%)     1/14 (7.14%)     1/43 (2.33%)  
# events     0     0     1     1  
Folliculitis        
# participants affected / at risk     1/14 (7.14%)     1/15 (6.67%)     0/14 (0.00%)     2/43 (4.65%)  
# events     1     1     0     2  
Groin Itch        
# participants affected / at risk     0/14 (0.00%)     1/15 (6.67%)     0/14 (0.00%)     1/43 (2.33%)  
# events     0     1     0     1  
loose nails - bilateral halux        
# participants affected / at risk     1/14 (7.14%)     0/15 (0.00%)     0/14 (0.00%)     1/43 (2.33%)  
# events     1     0     0     1  
Skin Lesion        
# participants affected / at risk     1/14 (7.14%)     1/15 (6.67%)     0/14 (0.00%)     2/43 (4.65%)  
# events     1     1     0     2  
Skin Rash, unspecified        
# participants affected / at risk     2/14 (14.29%)     1/15 (6.67%)     1/14 (7.14%)     4/43 (9.30%)  
# events     2     1     1     4  
Tinea Cruris        
# participants affected / at risk     0/14 (0.00%)     0/15 (0.00%)     2/14 (14.29%)     2/43 (4.65%)  
# events     0     0     2     2  
Social circumstances          
Substance Misuse        
# participants affected / at risk     1/14 (7.14%)     1/15 (6.67%)     0/14 (0.00%)     2/43 (4.65%)  
# events     1     1     0     2  
Events were collected by systematic assessment



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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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