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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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.
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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
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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 ]

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

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) ]

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) ]

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) ]

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 ]

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 ]

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 ]

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

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

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┬ácopies/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 ]

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 ]

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

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

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 ]


  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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