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Phase IIB Pilot of Atazanavir + Raltegravir (SPARTAN)

This study has been terminated.
(Efficacy endpoint met, but overall experimental dosing regimen not considered optimal to support further clinical development in this population.)
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00768989
First received: October 6, 2008
Last updated: February 22, 2012
Last verified: February 2012
Results First Received: October 19, 2011  
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
Drug: Raltegravir
Drug: Ritonavir
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
Participants were enrolled from sites in Argentina (n=21 randomized), France (n=26 randomized), and the United States (n=47 randomized).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 167 participants enrolled, 94 were randomized to treatment; 1 withdrew consent after randomization but prior to study dosing. Of the 73 not randomized, 5 withdrew consent, 1 lost to follow up; 1 poor/noncompliance; 61 no longer met study criteria, and 5 for other reasons. The trial was terminated early.

Reporting Groups
  Description
Atazanavir + Raltegravir Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily
Atazanavir + Ritonavir + Tenofovir/Emtricitabine Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily

Participant Flow for 3 periods

Period 1:   Prior to Week 24
    Atazanavir + Raltegravir     Atazanavir + Ritonavir + Tenofovir/Emtricitabine  
STARTED     63     30  
COMPLETED     59     27  
NOT COMPLETED     4     3  
Withdrawal by Subject                 1                 0  
Adverse Event                 3                 0  
Lost to Follow-up                 0                 1  
Protocol Violation                 0                 2  

Period 2:   Week 24 to Prior to Week 36
    Atazanavir + Raltegravir     Atazanavir + Ritonavir + Tenofovir/Emtricitabine  
STARTED     59     27  
COMPLETED     51     27  
NOT COMPLETED     8     0  
Adverse Event                 1                 0  
Lack of Efficacy                 6                 0  
Withdrawal by Subject                 1                 0  

Period 3:   On or After Week 36
    Atazanavir + Raltegravir     Atazanavir + Ritonavir + Tenofovir/Emtricitabine  
STARTED     51     27  
COMPLETED     0     0  
NOT COMPLETED     51     27  
Lack of Efficacy                 1                 0  
Adverse Event                 0                 1  
Lost to Follow-up                 1                 0  
Poor Compliance                 1                 0  
Protocol Violation                 1                 0  
Did not attend termination visit                 2                 0  
Sponsor Termination                 45                 26  



  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
Atazanavir + Raltegravir Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily
Atazanavir + Ritonavir + Tenofovir/Emtricitabine Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
Total Total of all reporting groups

Baseline Measures
    Atazanavir + Raltegravir     Atazanavir + Ritonavir + Tenofovir/Emtricitabine     Total  
Number of Participants  
[units: participants]
  63     30     93  
Age  
[units: years]
Mean ± Standard Deviation
  39.5  ± 10.90     41.6  ± 10.87     40.2  ± 10.88  
Gender  
[units: participants]
     
Female     8     2     10  
Male     55     28     83  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     1     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     8     6     14  
White     54     23     77  
More than one race     0     0     0  
Unknown or Not Reported     1     0     1  
HIV RNA Level at Baseline  
[units: log10┬ácopies/mL]
Mean ± Standard Deviation
  4.9  ± 0.57     4.9  ± 0.66     4.9  ± 0.60  
HIV RNA Distribution at Baseline  
[units: Participants]
     
< 30,000 copies/mL     14     7     21  
30,000 to <100,000 copies/mL     15     10     25  
100,000 to <500,000 copies/mL     26     10     36  
>=500,000 copies/mL     8     3     11  
Mean Cluster of Differentiation 4 (CD4) Cell Count at Baseline  
[units: cells/mm^3]
Mean ± Standard Deviation
  256.2  ± 116.79     261.2  ± 134.93     257.8  ± 122.21  
CD4 Distribution at Baseline  
[units: Participants]
     
< 50 cells/mm^3     5     4     9  
50 to < 100 cells/mm^3     1     1     2  
100 to < 200 cells/mm^3     13     3     16  
200 to < 350 cells/mm^3     29     13     42  
350 to < 500 cells/mm^3     14     9     23  
>= 500 cells/mm^3     1     0     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Level <50 Copies/mL at Week 24   [ Time Frame: At Week 24 from Baseline ]

2.  Secondary:   Number of Nonresponders at Week 8   [ Time Frame: At Week 8 from Baseline ]

3.  Secondary:   Number of Participants With HIV RNA Levels <50 Copies/mL at Weeks 48 and 96   [ Time Frame: At Weeks 48 and 96 from Baseline ]

4.  Secondary:   Number of Participants With HIV RNA Levels <400 Copies/mL at Week 24   [ Time Frame: At Week 24 from Baseline ]

5.  Secondary:   Number of Participants With HIV RNA Levels <400 Copies/mL at Week 48   [ Time Frame: At Week 48 from Baseline ]

6.  Secondary:   Number of Participants With HIV RNA Levels <400 Copies/mL at Week 96   [ Time Frame: At Week 96 from Baseline ]

7.  Secondary:   Mean Change From Baseline in Absolute Cluster of Differentiation 4 Cell Count   [ Time Frame: From Baseline to Weeks 2, 4, 8, 12, 16, 20, and 24 ]

8.  Secondary:   Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Death as Outcome, AEs Leading to Discontinuation, SAEs Leading to Discontinuation   [ Time Frame: Week 1 to Week 96, continuously ]

9.  Secondary:   Baseline and Mean Change From Baseline in Total Cholesterol Levels   [ Time Frame: From Baseline to Week 24 and Week 48 ]

10.  Secondary:   Mean Change From Baseline in Total Bilirubin Level   [ Time Frame: From Baseline to Week 24 and Week 48 ]

11.  Secondary:   Mean Change From Baseline in Electrocardiogram Findings   [ Time Frame: From Baseline to Week 24 ]

12.  Secondary:   Atazanavir Maximum Observed Plasma Concentration (Cmax) in 1 Dosing Interval   [ Time Frame: At Week 2 from Baseline ]

13.  Secondary:   Raltegravir Cmax in 1 Dosing Interval   [ Time Frame: At Week 2 from Baseline ]

14.  Secondary:   Atazanavir Time of Maximum Observed Plasma Concentration (Tmax)   [ Time Frame: At Week 2 from Baseline ]

15.  Secondary:   Raltegravir Tmax   [ Time Frame: At Week 2 from Baseline ]

16.  Secondary:   Atazanavir Trough Plasma Concentration (Cmin) 12 Hours Postdose   [ Time Frame: At Week 2 from Baseline ]

17.  Secondary:   Raltegravir Cmin 12 Hours Postdose   [ Time Frame: At Week 2 from Baseline ]

18.  Secondary:   Atazanavir Cmin Prior to the Morning Dose   [ Time Frame: At Week 2 from Baseline ]

19.  Secondary:   Raltegravir Cmin Prior to the Morning Dose   [ Time Frame: At Week 2 from Baseline ]

20.  Secondary:   Atazanavir Area Under the Concentration Curve From Time 0 to 12 Hours (AUC [0-12h]) in 1 Dosing Interval   [ Time Frame: At Week 2 from Baseline ]

21.  Secondary:   Raltegravir AUC (0-12h) in 1 Dosing Interval   [ Time Frame: At Week 2 from Baseline ]

22.  Secondary:   Atazanavir Area Under the Concentration Curve From Time 0 to 24 Hours (AUC [0-24h]) in 1 Dosing Interval   [ Time Frame: At Week 2 from Baseline ]

23.  Secondary:   Atazanavir Individual Inhibitory Quotient (IQ)   [ Time Frame: At Week 2 from Baseline ]

24.  Secondary:   Atazanavir Terminal Elimination Half Life   [ Time Frame: At Week 2 from Baseline ]

25.  Secondary:   Raltegravir Terminal Elimination Half Life   [ Time Frame: At Week 2 from Baseline ]

26.  Secondary:   Number of Participants With Hematology Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Among All Treated Participants   [ Time Frame: While on treatment from Baseline through Week 96 ]

27.  Secondary:   Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4   [ Time Frame: While on treatment from Baseline through Week 96 ]

28.  Secondary:   Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 (Continued)   [ Time Frame: While on treatment from Baseline through Week 96 ]

29.  Secondary:   Number of Participants With Enzyme and Urine Laboratory Test Results With Worst Toxicity of Grades 1 to 4   [ Time Frame: While on treatment from Baseline through Week 96 ]


  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
No text entered.


  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: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


No publications provided by Bristol-Myers Squibb

Publications automatically indexed to this study:

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00768989     History of Changes
Other Study ID Numbers: AI424-376
Study First Received: October 6, 2008
Results First Received: October 19, 2011
Last Updated: February 22, 2012
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration