Atazanavir/Ritonavir, Once Daily + Raltegravir, Twice Daily, Switch Study in HIV-1—Infected Patients (SPARTAN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01332227
First received: April 7, 2011
Last updated: February 2, 2015
Last verified: February 2015
Results First Received: September 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV, Combination Therapy
Interventions: Drug: Atazanavir
Drug: Ritonavir (heat-stable)
Drug: Raltegravir
Drug: 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 132 patients enrolled, 109 were randomized to receive treatment, and 23 patients were not randomized for the following reasons: 10 did not meet study criteria; 5 withdrew consent; 3 were lost to follow-up, and 5 withdrew for other reasons.

Reporting Groups
  Description
Atazanavir/Ritonavir + Raltegravir Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
Atazanavir/Ritonavir + Tenofovir/Emtricitabine Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.

Participant Flow:   Overall Study
    Atazanavir/Ritonavir + Raltegravir     Atazanavir/Ritonavir + Tenofovir/Emtricitabine  
STARTED     72 [1]   37 [1]
COMPLETED     56     32  
NOT COMPLETED     16     5  
Adverse Event                 4                 1  
Withdrawal by Subject                 5                 1  
Lost to Follow-up                 2                 0  
Lack of Efficacy                 3                 1  
Poor compliance/noncompliance                 1                 1  
Patient moved from area                 1                 0  
Patient began prohibited medication                 0                 1  
[1] Participants who received treatment



  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.
All participants who received study drug

Reporting Groups
  Description
Atazanavir/Ritonavir + Raltegravir Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
Atazanavir/Ritonavir + Tenofovir/Emtricitabine Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
Total Total of all reporting groups

Baseline Measures
    Atazanavir/Ritonavir + Raltegravir     Atazanavir/Ritonavir + Tenofovir/Emtricitabine     Total  
Number of Participants  
[units: participants]
  72     37     109  
Age [1]
[units: Years]
Mean (Standard Deviation)
  43.1  (9.26)     44.0  (10.38)     43.4  (9.62)  
Age [2]
[units: Years]
Median (Full Range)
  44.0    (25 to 67)     44.0    (25 to 69)     44.0    (25 to 69)  
Age, Customized  
[units: Participants]
     
< 65 years     69     36     105  
65-85 years     3     1     4  
Gender  
[units: Participants]
     
Female     14     6     20  
Male     58     31     89  
Ethnicity (NIH/OMB)  
[units: Participants]
     
Hispanic or Latino     5     1     6  
Not Hispanic or Latino     29     13     42  
Unknown or Not Reported     38     23     61  
Race/Ethnicity, Customized  
[units: Participants]
     
White     54     24     78  
Black or African American     8     6     14  
Hispanic     2     0     2  
Unknown     8     7     15  
Mean CD4 count  
[units: Cells/mm^3]
Mean (Standard Deviation)
  587.7  (252.09)     630.9  (270.02)     601.5  (257.48)  
Median CD4 count  
[units: Cells/mm^3]
Median (Full Range)
  588.5    (10 to 1511)     639.5    (159 to 1395)     593.0    (10 to 1511)  
Cardiovascular disease risk factors [3]
[units: Participants]
     
Hypertension     5     6     11  
Diabetes mellitus     3     1     4  
Current smoker     27     11     38  
Previous smoker     7     8     15  
Family history of premature coronary heart disease     4     0     4  
[1] Mean age
[2] Median age
[3] Hypertension=systolic blood pressure/diastolic blood pressure >140/90 mm Hg or patient was taking antihypertensive medication; family history of coronary heart disease=father, mother, or sibling (male <55 years of age, and mother <65 years of age).



  Outcome Measures
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1.  Primary:   Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24   [ Time Frame: From Day 1 to Week 24 ]

2.  Secondary:   Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48   [ Time Frame: From Day 1 to Week 48 ]

3.  Secondary:   Number of Participants With Virologic Rebound at Weeks 24 and 48   [ Time Frame: Day 1 to Weeks 28 and 48 ]

4.  Secondary:   Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24   [ Time Frame: Day 1 to Week 24 ]

5.  Secondary:   Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48   [ Time Frame: Day 1 to Week 48 ]

6.  Secondary:   Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs   [ Time Frame: Day 1 to Week 48 ]

7.  Secondary:   Mean Changes in Fasting Lipid Levels From Baseline to Week 48   [ Time Frame: From Baseline to Week 48 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


No publications provided


Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01332227     History of Changes
Other Study ID Numbers: AI424-402, 2009-017032-41
Study First Received: April 7, 2011
Results First Received: September 19, 2014
Last Updated: February 2, 2015
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Ministry of Health
Italy: The Italian Medicines Agency
Poland: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency