Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Pilot Study Of A Novel Treatment Regimen, Maraviroc + Ritonavir Boosted Atazanavir, In Treatment Naive HIV-Infected Patients

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00827112
First received: January 21, 2009
Last updated: June 8, 2012
Last verified: June 2012
Results First Received: July 11, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Human Immunodeficiency Virus-1
Intervention: Drug: maraviroc

  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
No text entered.

Reporting Groups
  Description
Maraviroc+ Atazanavir / Ritonavir Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
Atazanavir / Ritonavir + Emtricitabine / Tenofovir Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.

Participant Flow:   Overall Study
    Maraviroc+ Atazanavir / Ritonavir     Atazanavir / Ritonavir + Emtricitabine / Tenofovir  
STARTED     65     64  
Treated     60     61  
COMPLETED     50     52  
NOT COMPLETED     15     12  
Adverse Event                 2                 0  
Lack of Efficacy                 2                 0  
Lost to Follow-up                 3                 2  
Pregnancy                 0                 1  
Protocol Violation                 0                 2  
Withdrawal by Subject                 2                 1  
Randomized but not treated                 5                 3  
Unspecified                 1                 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
Maraviroc+ Atazanavir / Ritonavir Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
Atazanavir / Ritonavir + Emtricitabine / Tenofovir Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
Total Total of all reporting groups

Baseline Measures
    Maraviroc+ Atazanavir / Ritonavir     Atazanavir / Ritonavir + Emtricitabine / Tenofovir     Total  
Number of Participants  
[units: participants]
  60     61     121  
Age  
[units: Years]
Mean ± Standard Deviation
  38.3  ± 10.2     35.3  ± 10.5     36.8  ± 10.4  
Gender  
[units: Participants]
     
Female     4     9     13  
Male     56     52     108  



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than 50 Copies/Milliliter (mL)   [ Time Frame: Week 48 ]

Measure Type Primary
Measure Title Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than 50 Copies/Milliliter (mL)
Measure Description No text entered.
Time Frame Week 48  
Safety Issue No  

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.
Full Analysis Set (FAS) population included those participants who had taken at least one dose of the study drug, had baseline and at least one post baseline measurement.

Reporting Groups
  Description
Maraviroc+ Atazanavir / Ritonavir Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
Atazanavir / Ritonavir + Emtricitabine / Tenofovir Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.

Measured Values
    Maraviroc+ Atazanavir / Ritonavir     Atazanavir / Ritonavir + Emtricitabine / Tenofovir  
Number of Participants Analyzed  
[units: participants]
  59     61  
Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than 50 Copies/Milliliter (mL)  
[units: Percentage of participants]
Number ( 95% Confidence Interval )
  74.60  
  ( 63.47 to 85.69 )  
  83.60  
  ( 74.32 to 92.90 )  

No statistical analysis provided for Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than 50 Copies/Milliliter (mL)



2.  Secondary:   HIV-1 RNA Levels at Baseline   [ Time Frame: Baseline ]

Measure Type Secondary
Measure Title HIV-1 RNA Levels at Baseline
Measure Description No text entered.
Time Frame Baseline  
Safety Issue No  

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.
FAS population included those participants who had taken at least one dose of the study drug, had baseline and at least one post baseline measurement.

Reporting Groups
  Description
Maraviroc+ Atazanavir / Ritonavir Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
Atazanavir / Ritonavir + Emtricitabine / Tenofovir Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.

Measured Values
    Maraviroc+ Atazanavir / Ritonavir     Atazanavir / Ritonavir + Emtricitabine / Tenofovir  
Number of Participants Analyzed  
[units: participants]
  59     61  
HIV-1 RNA Levels at Baseline  
[units: copies/mL]
Mean ± Standard Deviation
  84982  ± 127008     114827  ± 149638  

No statistical analysis provided for HIV-1 RNA Levels at Baseline



3.  Secondary:   Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14   [ Time Frame: Baseline , Days 4, 7, 10 and 14 ]

Measure Type Secondary
Measure Title Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14
Measure Description Plasma HIV-1 RNA levels were evaluated for first 15 participants enrolled at United States (U.S) sites only.
Time Frame Baseline , Days 4, 7, 10 and 14  
Safety Issue No  

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.
First 15 participants who were enrolled at U.S sites and had taken the study drug .

Reporting Groups
  Description
Maraviroc+ Atazanavir / Ritonavir Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
Atazanavir / Ritonavir + Emtricitabine / Tenofovir Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.

Measured Values
    Maraviroc+ Atazanavir / Ritonavir     Atazanavir / Ritonavir + Emtricitabine / Tenofovir  
Number of Participants Analyzed  
[units: participants]
  14     16  
Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14  
[units: copies/mL]
Mean ± Standard Deviation
   
Change at Day 4     1800.00  ± 37351.09     -46479.40  ± 62259.15  
Change at Day 7     -36947.90  ± 28463.80     -52137.10  ± 68684.14  
Change at Day 10     -58595.80  ± 66157.66     -54925.90  ± 70846.93  
Change at Day 14     -47271.60  ± 38234.34     -55449.90  ± 71207.16  

No statistical analysis provided for Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14



4.  Secondary:   Maximum Observed Plasma Concentration (Cmax) of Maraviroc   [ Time Frame: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose) ]

Measure Type Secondary
Measure Title Maximum Observed Plasma Concentration (Cmax) of Maraviroc
Measure Description No text entered.
Time Frame Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)  
Safety Issue No  

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.
Pharmacokinetic (PK) parameter analysis population included first 15 participants treated with maraviroc.

Reporting Groups
  Description
Maraviroc+ Atazanavir / Ritonavir Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.

Measured Values
    Maraviroc+ Atazanavir / Ritonavir  
Number of Participants Analyzed  
[units: participants]
  15  
Maximum Observed Plasma Concentration (Cmax) of Maraviroc  
[units: nanogram (ng)/mL]
Median ( Full Range )
  650  
  ( 178 to 1490 )  

No statistical analysis provided for Maximum Observed Plasma Concentration (Cmax) of Maraviroc



5.  Secondary:   Minimum Observed Plasma Concentration (Cmin) of Maraviroc   [ Time Frame: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose) ]

Measure Type Secondary
Measure Title Minimum Observed Plasma Concentration (Cmin) of Maraviroc
Measure Description No text entered.
Time Frame Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)  
Safety Issue No  

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.
PK parameter analysis population included first 15 participants treated with maraviroc.

Reporting Groups
  Description
Maraviroc+ Atazanavir / Ritonavir Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.

Measured Values
    Maraviroc+ Atazanavir / Ritonavir  
Number of Participants Analyzed  
[units: participants]
  15  
Minimum Observed Plasma Concentration (Cmin) of Maraviroc  
[units: ng/mL]
Median ( Full Range )
  37.0  
  ( 8.4 to 92.7 )  

No statistical analysis provided for Minimum Observed Plasma Concentration (Cmin) of Maraviroc



6.  Secondary:   Average Observed Plasma Concentration (Cavg) of Maraviroc   [ Time Frame: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose) ]

Measure Type Secondary
Measure Title Average Observed Plasma Concentration (Cavg) of Maraviroc
Measure Description Cavg was described as area under the plasma concentration-time profile from time zero to time 24 hours (AUC24) divided by the dosing interval (AUC24/ 24).
Time Frame Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)  
Safety Issue No  

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.
PK parameter analysis population included first 15 participants treated with maraviroc.

Reporting Groups
  Description
Maraviroc+ Atazanavir / Ritonavir Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.

Measured Values
    Maraviroc+ Atazanavir / Ritonavir  
Number of Participants Analyzed  
[units: participants]
  15  
Average Observed Plasma Concentration (Cavg) of Maraviroc  
[units: ng/mL]
Mean ± Standard Deviation
  185.10  ± 71.08  

No statistical analysis provided for Average Observed Plasma Concentration (Cavg) of Maraviroc



7.  Secondary:   Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24, 48 and 96   [ Time Frame: Baseline, Week 16, Week 24, Week 48, Week 96 ]

Measure Type Secondary
Measure Title Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24, 48 and 96
Measure Description No text entered.
Time Frame Baseline, Week 16, Week 24, Week 48, Week 96  
Safety Issue No  

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.
FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here “n” signified participants who received the study drug and evaluated at the time point.

Reporting Groups
  Description
Maraviroc+ Atazanavir / Ritonavir Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
Atazanavir / Ritonavir + Emtricitabine / Tenofovir Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.

Measured Values
    Maraviroc+ Atazanavir / Ritonavir     Atazanavir / Ritonavir + Emtricitabine / Tenofovir  
Number of Participants Analyzed  
[units: participants]
  59     61  
Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24, 48 and 96  
[units: log10 copies/ml]
Mean ± Standard Deviation
   
Baseline (n= 59, 61)     84982  ± 127008     114827  ± 149638  
Change at Week 16 (n= 54, 58)     -89859.1  ± 131317.35     -107684.6  ± 149476.47  
Change at Week 24 (n= 56, 58)     -87241.2  ± 129638.57     -110498.1  ± 149836.29  
Change at Week 48 (n= 53, 54)     -82343.4  ± 119356.62     -115582.9  ± 153705.26  
Change at Week 96 (n= 49, 51)     -80117.7  ± 121443.50     -99662.6  ± 116525.87  

No statistical analysis provided for Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24, 48 and 96



8.  Secondary:   Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA   [ Time Frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96 ]

Measure Type Secondary
Measure Title Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA
Measure Description No text entered.
Time Frame Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96  
Safety Issue No  

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.
FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here “n” signified participants who received the study drug and evaluated at the time point.

Reporting Groups
  Description
Maraviroc+ Atazanavir / Ritonavir Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
Atazanavir / Ritonavir + Emtricitabine / Tenofovir Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.

Measured Values
    Maraviroc+ Atazanavir / Ritonavir     Atazanavir / Ritonavir + Emtricitabine / Tenofovir  
Number of Participants Analyzed  
[units: participants]
  59     61  
Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA  
[units: Percentage of participants]
Number ( 95% Confidence Interval )
   
Week 2 (n= 55, 60)     0  
  ( 0 to 0 )  
  6.60  
  ( 0.35 to 12.77 )  
Week 4 (n= 57, 60)     8.50  
  ( 1.37 to 15.58 )  
  21.30  
  ( 11.03 to 31.59 )  
Week 8 (n= 57, 59)     47.50  
  ( 34.72 to 60.20 )  
  42.60  
  ( 30.21 to 55.03 )  
Week 12 (n= 55, 59)     61.00  
  ( 48.57 to 73.46 )  
  62.30  
  ( 50.13 to 74.46 )  
Week 16 (n= 54, 58)     72.90  
  ( 61.54 to 84.23 )  
  73.80  
  ( 62.73 to 84.81 )  
Week 20 (n= 56, 57)     71.20  
  ( 59.63 to 82.74 )  
  83.61  
  ( 74.32 to 92.90 )  
Week 24 (n= 56, 58)     81.36  
  ( 71.42 to 91.29 )  
  88.52  
  ( 80.53 to 96.52 )  
Week 32 (n= 55, 57)     79.66  
  ( 69.39 to 89.93 )  
  88.52  
  ( 80.53 to 96.52 )  
Week 40 (n= 54, 55)     81.36  
  ( 71.42 to 91.29 )  
  88.52  
  ( 80.53 to 96.52 )  
Week 48 (n= 53, 54)     74.58  
  ( 63.47 to 85.69 )  
  83.61  
  ( 74.32 to 92.90 )  
Week 60 (n= 52, 53)     67.80  
  ( 55.87 to 79.72 )  
  85.25  
  ( 76.35 to 94.15 )  
Week 72 (n= 52, 53)     74.58  
  ( 63.47 to 85.69 )  
  81.97  
  ( 72.32 to 91.62 )  
Week 84 (n= 50, 52)     76.27  
  ( 65.42 to 87.13 )  
  83.61  
  ( 74.32 to 92.90 )  
Week 96 (n= 49, 51)     67.80  
  ( 55.87 to 79.72 )  
  81.97  
  ( 72.32 to 91.62 )  

No statistical analysis provided for Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA



9.  Secondary:   Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA   [ Time Frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96 ]

Measure Type Secondary
Measure Title Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA
Measure Description No text entered.
Time Frame Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96  
Safety Issue No  

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.
FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here “n” signified participants who received the study drug and evaluated at the time point.

Reporting Groups
  Description
Maraviroc+ Atazanavir / Ritonavir Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
Atazanavir / Ritonavir + Emtricitabine / Tenofovir Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.

Measured Values
    Maraviroc+ Atazanavir / Ritonavir     Atazanavir / Ritonavir + Emtricitabine / Tenofovir  
Number of Participants Analyzed  
[units: participants]
  59     61  
Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA  
[units: Percentage of participants]
Number ( 95% Confidence Interval )
   
Week 2 (n= 55, 60)     27.12  
  ( 15.77 to 38.46 )  
  34.43  
  ( 22.50 to 46.35 )  
Week 4 (n= 57, 60)     50.85  
  ( 38.09 to 63.60 )  
  52.46  
  ( 39.93 to 64.99 )  
Week 8 (n= 57, 59)     79.66  
  ( 69.39 to 89.93 )  
  77.05  
  ( 66.50 to 87.60 )  
Week 12 (n= 55, 59)     89.83  
  ( 82.12 to 97.54 )  
  88.52  
  ( 80.53 to 96.52 )  
Week 16 (n= 54, 58)     88.14  
  ( 79.88 to 96.39 )  
  91.80  
  ( 84.92 to 98.69 )  
Week 20 (n= 56, 57)     89.83  
  ( 82.12 to 97.54 )  
  93.44  
  ( 87.23 to 99.65 )  
Week 24 (n= 56, 58)     91.53  
  ( 84.42 to 98.63 )  
  93.44  
  ( 87.23 to 99.65 )  
Week 32 (n= 55, 57)     89.83  
  ( 82.12 to 97.54 )  
  93.44  
  ( 87.23 to 99.65 )  
Week 40 (n= 54, 55)     91.53  
  ( 84.42 to 98.63 )  
  90.16  
  ( 82.69 to 97.64 )  
Week 48 (n= 53, 54)     89.83  
  ( 82.12 to 97.54 )  
  86.89  
  ( 78.41 to 95.36 )  
Week 60 (n= 52, 53)     86.44  
  ( 77.70 to 95.18 )  
  86.89  
  ( 78.41 to 95.36 )  
Week 72 (n= 52, 53)     86.44  
  ( 77.70 to 95.18 )  
  85.25  
  ( 76.35 to 94.15 )  
Week 84 (n= 50, 52)     81.36  
  ( 71.42 to 91.29 )  
  85.25  
  ( 76.35 to 94.15 )  
Week 96 (n= 49, 51)     77.97  
  ( 67.39 to 88.54 )  
  83.61  
  ( 74.32 to 92.90 )  

No statistical analysis provided for Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA



10.  Secondary:   Time to Loss of Virological Response (TLOVR)   [ Time Frame: Baseline through Week 96 ]

Measure Type Secondary
Measure Title Time to Loss of Virological Response (TLOVR)
Measure Description TLOVR (virological failure) was defined as the time from first dose of study treatment (Day 1) until the time of virologic failure using the time to loss of virologic response algorithm.
Time Frame Baseline through Week 96  
Safety Issue No  

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.
FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement.

Reporting Groups
  Description
Maraviroc+ Atazanavir / Ritonavir Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
Atazanavir / Ritonavir + Emtricitabine / Tenofovir Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.

Measured Values
    Maraviroc+ Atazanavir / Ritonavir     Atazanavir / Ritonavir + Emtricitabine / Tenofovir  
Number of Participants Analyzed  
[units: participants]
  59     61  
Time to Loss of Virological Response (TLOVR)  
[units: Days]
Mean ± Standard Error
  436.2  ± 22.5     463.8  ± 16.1  

No statistical analysis provided for Time to Loss of Virological Response (TLOVR)



11.  Secondary:   Time-Averaged Difference (TAD) in log10 Viral Load   [ Time Frame: Week 16, Week 24, Week 48, Week 96 ]

Measure Type Secondary
Measure Title Time-Averaged Difference (TAD) in log10 Viral Load
Measure Description TAD was calculated as area under the curve of HIV divided by time period minus baseline HIV where HIV was denoted as HIV-1 RNA (log10 copies/mL).
Time Frame Week 16, Week 24, Week 48, Week 96  
Safety Issue No  

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.
FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here N (Number of participants analyzed) signified participants evaluable for the measure.

Reporting Groups
  Description
Maraviroc+ Atazanavir / Ritonavir Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
Atazanavir / Ritonavir + Emtricitabine / Tenofovir Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.

Measured Values
    Maraviroc+ Atazanavir / Ritonavir     Atazanavir / Ritonavir + Emtricitabine / Tenofovir  
Number of Participants Analyzed  
[units: participants]
  51     52  
Time-Averaged Difference (TAD) in log10 Viral Load  
[units: log10 copies/mL]
Mean ± Standard Error
   
Week 16     -2.459  ± 0.046     -2.402  ± 0.045  
Week 24     -2.663  ± 0.048     -2.626  ± 0.046  
Week 48     -2.897  ± 0.046     -2.868  ± 0.050  
Week 96     -2.998  ± 0.055     -3.001  ± 0.053  

No statistical analysis provided for Time-Averaged Difference (TAD) in log10 Viral Load



12.  Secondary:   Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96   [ Time Frame: Baseline, Week 16, Week 24, Week 48, Week 96 ]

Measure Type Secondary
Measure Title Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96
Measure Description No text entered.
Time Frame Baseline, Week 16, Week 24, Week 48, Week 96  
Safety Issue No  

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.
FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here “n” signified participants who received the study drug and evaluated at the time point.

Reporting Groups
  Description
Maraviroc+ Atazanavir / Ritonavir Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
Atazanavir / Ritonavir + Emtricitabine / Tenofovir Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.

Measured Values
    Maraviroc+ Atazanavir / Ritonavir     Atazanavir / Ritonavir + Emtricitabine / Tenofovir  
Number of Participants Analyzed  
[units: participants]
  59     61  
Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96  
[units: cells/microliter (cells/mcL)]
Mean ± Standard Deviation
   
Baseline (n= 59, 61)     357.70  ± 123.53     390.00  ± 152.34  
Change at Week 16 (n= 54, 58)     169.60  ± 117.20     139.80  ± 102.62  
Change at Week 24 (n= 54, 57)     188.90  ± 125.14     173.30  ± 130.55  
Change at Week 48 (n= 52, 53)     215.70  ± 166.59     226.60  ± 138.04  
Change at Week 96 (n= 50, 51)     287.50  ± 173.23     298.50  ± 160.54  

No statistical analysis provided for Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96



13.  Secondary:   Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96   [ Time Frame: Baseline, Week 16, Week 24, Week 48, Week 96 ]

Measure Type Secondary
Measure Title Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96
Measure Description No text entered.
Time Frame Baseline, Week 16, Week 24, Week 48, Week 96  
Safety Issue No  

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.
FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here “n” signified participants who received the study drug and evaluated at the time point.

Reporting Groups
  Description
Maraviroc+ Atazanavir / Ritonavir Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
Atazanavir / Ritonavir + Emtricitabine / Tenofovir Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.

Measured Values
    Maraviroc+ Atazanavir / Ritonavir     Atazanavir / Ritonavir + Emtricitabine / Tenofovir  
Number of Participants Analyzed  
[units: participants]
  59     61  
Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96  
[units: cells/mcL]
Mean ± Standard Deviation
   
Baseline (n= 59, 61)     931.10  ± 446.26     1125.60  ± 735.08  
Change at Week 16 (n= 54, 58)     63.70  ± 290.49     -153.80  ± 473.96  
Change at Week 24 (n= 54, 57)     6.20  ± 334.89     -178.00  ± 508.75  
Change at Week 48 (n= 52, 53)     -76.80  ± 354.48     -267.60  ± 574.22  
Change at Week 96 (n= 50, 51)     -63.00  ± 355.60     -231.40  ± 516.99  

No statistical analysis provided for Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96



14.  Secondary:   Number of Participants With Genotypic Resistance   [ Time Frame: Week 96 or Time of treatment failure ]

Measure Type Secondary
Measure Title Number of Participants With Genotypic Resistance
Measure Description Genotypic resistance was assessed for all participants at screening and was evaluated for protease inhibitors (PIs), Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs) using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96.
Time Frame Week 96 or Time of treatment failure  
Safety Issue No  

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.
FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement.

Reporting Groups
  Description
Maraviroc+ Atazanavir / Ritonavir Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
Atazanavir / Ritonavir + Emtricitabine / Tenofovir Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.

Measured Values
    Maraviroc+ Atazanavir / Ritonavir     Atazanavir / Ritonavir + Emtricitabine / Tenofovir  
Number of Participants Analyzed  
[units: participants]
  59     61  
Number of Participants With Genotypic Resistance  
[units: Participants]
  0     0  

No statistical analysis provided for Number of Participants With Genotypic Resistance



15.  Secondary:   Number of Participants With Phenotypic Resistance   [ Time Frame: Week 96 or Time of treatment failure ]

Measure Type Secondary
Measure Title Number of Participants With Phenotypic Resistance
Measure Description Phenotypic resistance was assessed for all participants at screening and was evaluated for PIs, NRTIs, and NNRTIs using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96.
Time Frame Week 96 or Time of treatment failure  
Safety Issue No  

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.
FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement.

Reporting Groups
  Description
Maraviroc+ Atazanavir / Ritonavir Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
Atazanavir / Ritonavir + Emtricitabine / Tenofovir Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.

Measured Values
    Maraviroc+ Atazanavir / Ritonavir     Atazanavir / Ritonavir + Emtricitabine / Tenofovir  
Number of Participants Analyzed  
[units: participants]
  59     61  
Number of Participants With Phenotypic Resistance  
[units: Participants]
  0     0  

No statistical analysis provided for Number of Participants With Phenotypic Resistance



16.  Secondary:   Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay   [ Time Frame: Baseline to Week 96 or Time of treatment Failure ]

Measure Type Secondary
Measure Title Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay
Measure Description Viral tropism was determined using the trofile assay with enhanced sensitivity for participants with HIV-1 RNA greater than equal to 1000 copies/mL. The enhanced trofile assay had the sensitivity to detect 100 percent of spiked samples when C-X-C chemokine receptor type 4 {CXCR4} [X4]-using HIV-1 RNA represented 0.3 percent of the total viral population.
Time Frame Baseline to Week 96 or Time of treatment Failure  
Safety Issue No  

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.
FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement.

Reporting Groups
  Description
Maraviroc+ Atazanavir / Ritonavir Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
Atazanavir / Ritonavir + Emtricitabine / Tenofovir Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.

Measured Values
    Maraviroc+ Atazanavir / Ritonavir     Atazanavir / Ritonavir + Emtricitabine / Tenofovir  
Number of Participants Analyzed  
[units: participants]
  60     61  
Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay  
[units: Participants]
   
Baseline     60     61  
Week 96 or Time of treatment Failure     0     0  

No statistical analysis provided for Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay




  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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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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00827112     History of Changes
Other Study ID Numbers: A4001078
Study First Received: January 21, 2009
Results First Received: July 11, 2011
Last Updated: June 8, 2012
Health Authority: United States: Food and Drug Administration