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A Pilot Study Of A Novel Treatment Regimen, Maraviroc + Ritonavir Boosted Atazanavir, In Treatment Naive HIV-Infected Patients
This study has been completed.
Study NCT00827112   Information provided by ViiV Healthcare

First Received on January 21, 2009.   Last Updated on October 19, 2011   History of Changes
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 (QD) along with atazanavir/ritonavir 300 mg/100 mg tablets QD were orally administered for 48 weeks.
Atazanavir / Ritonavir + Emtricitabine / Tenofovir Atazanavir/ritonavir 300 mg/100 mg tablets QD along with emtricitabine/tenofovir 200 mg/300 mg tablets QD were orally administered for 48 weeks.

Participant Flow:   Overall Study
    Maraviroc+ Atazanavir / Ritonavir     Atazanavir / Ritonavir + Emtricitabine / Tenofovir  
STARTED     65     64  
Treated     60     61  
COMPLETED     0     0  
NOT COMPLETED     65     64  
Adverse Event                 2                 0  
Lack of Efficacy                 1                 0  
Lost to Follow-up                 3                 2  
Pregnancy                 0                 1  
Protocol Violation                 0                 2  
Withdrawal by Subject                 1                 1  
Randomized but not treated                 5                 3  
Unspecified                 0                 1  
Ongoing                 53                 54  



  Baseline Characteristics
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Reporting Groups
  Description
Maraviroc+ Atazanavir / Ritonavir Maraviroc 150 milligram (mg) tablets once daily (QD) along with atazanavir/ritonavir 300 mg/100 mg tablets QD were orally administered for 48 weeks.
Atazanavir / Ritonavir + Emtricitabine / Tenofovir Atazanavir/ritonavir 300 mg/100 mg tablets QD along with emtricitabine/tenofovir 200 mg/300 mg tablets QD were orally administered for 48 weeks.

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 ]
  Show Outcome Measure 1

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

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 ]
  Show Outcome Measure 3

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) ]
  Show Outcome Measure 4

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) ]
  Show Outcome Measure 5

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) ]
  Show Outcome Measure 6

7.  Secondary:   Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24 and 48   [ Time Frame: Baseline, weeks 16, 24 and 48 ]
  Show Outcome Measure 7

8.  Secondary:   Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA   [ Time Frame: Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48 ]
  Show Outcome Measure 8

9.  Secondary:   Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA   [ Time Frame: Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48 ]
  Show Outcome Measure 9

10.  Secondary:   Time-Averaged Difference (TAD) in log10 Viral Load   [ Time Frame: Weeks 16, 24 and 48 ]
  Show Outcome Measure 10

11.  Secondary:   Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts   [ Time Frame: Baseline, weeks 16, 24 and 48 ]
  Show Outcome Measure 11

12.  Secondary:   Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count   [ Time Frame: Baseline and weeks 16, 24 and 48 ]
  Show Outcome Measure 12

13.  Secondary:   Number of Participants With Genotypic Resistance   [ Time Frame: Week 48 or Time of treatment failure ]
  Show Outcome Measure 13

14.  Secondary:   Number of Participants With Phenotypic Resistance   [ Time Frame: Week 48 or Time of treatment failure ]
  Show Outcome Measure 14

15.  Secondary:   Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay   [ Time Frame: Baseline to week 48 or Time of treatment Failure ]
  Show Outcome Measure 15

16.  Secondary:   Change From Baseline in Plasma log10 Viral Load at Week 96   [ Time Frame: Baseline and Week 96 ]
Results not yet posted.   Anticipated Posting Date:   07/2012   Safety Issue:   No

17.  Secondary:   Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA at Week 96   [ Time Frame: Week 96 ]
Results not yet posted.   Anticipated Posting Date:   07/2012   Safety Issue:   No

18.  Secondary:   Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA at Week 96   [ Time Frame: Week 96 ]
Results not yet posted.   Anticipated Posting Date:   07/2012   Safety Issue:   No

19.  Secondary:   Time to Loss of Virological Response (TLOVR)   [ Time Frame: Baseline through Week 96 ]
Results not yet posted.   Anticipated Posting Date:   07/2012   Safety Issue:   No

20.  Secondary:   Time-Averaged Difference (TAD) in log10 Viral Load at Week 96   [ Time Frame: Week 96 ]
Results not yet posted.   Anticipated Posting Date:   07/2012   Safety Issue:   No

21.  Secondary:   Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Week 96   [ Time Frame: Baseline and Week 96 ]
Results not yet posted.   Anticipated Posting Date:   07/2012   Safety Issue:   No

22.  Secondary:   Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Week 96   [ Time Frame: Baseline and Week 96 ]
Results not yet posted.   Anticipated Posting Date:   07/2012   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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.  


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: October 19, 2011
Health Authority: United States: Food and Drug Administration





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