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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.
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
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
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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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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
  Show 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 ]
  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, 48 and 96   [ Time Frame: Baseline, Week 16, Week 24, Week 48, Week 96 ]
  Show Outcome Measure 7

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 ]
  Show Outcome Measure 8

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 ]
  Show Outcome Measure 9

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

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

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 ]
  Show Outcome Measure 12

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 ]
  Show Outcome Measure 13

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

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

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 ]
  Show Outcome Measure 16


  Serious Adverse Events
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  Other Adverse Events
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Time Frame Baseline to follow-up period (28 days after the last dose of study)
Additional Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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

Other Adverse Events
    Maraviroc+ Atazanavir / Ritonavir     Atazanavir / Ritonavir + Emtricitabine/ Tenofovir  
Total, other (not including serious) adverse events      
# participants affected / at risk     55/60     58/61  
Eye disorders      
Ocular icterus * 1    
# participants affected / at risk     13/60 (21.67%)     7/61 (11.48%)  
Conjunctivitis * 1    
# participants affected / at risk     1/60 (1.67%)     5/61 (8.20%)  
Gastrointestinal disorders      
Abdominal pain upper * 1    
# participants affected / at risk     3/60 (5.00%)     0/61 (0.00%)  
Constipation * 1    
# participants affected / at risk     4/60 (6.67%)     1/61 (1.64%)  
Diarrhoea * 1    
# participants affected / at risk     15/60 (25.00%)     14/61 (22.95%)  
Haemorrhoids * 1    
# participants affected / at risk     4/60 (6.67%)     3/61 (4.92%)  
Nausea * 1    
# participants affected / at risk     6/60 (10.00%)     16/61 (26.23%)  
Vomiting * 1    
# participants affected / at risk     8/60 (13.33%)     6/61 (9.84%)  
General disorders      
Fatigue * 1    
# participants affected / at risk     3/60 (5.00%)     7/61 (11.48%)  
Pyrexia * 1    
# participants affected / at risk     4/60 (6.67%)     3/61 (4.92%)  
Hepatobiliary disorders      
Hyperbilirubinaemia * 1    
# participants affected / at risk     18/60 (30.00%)     16/61 (26.23%)  
Jaundice * 1    
# participants affected / at risk     10/60 (16.67%)     6/61 (9.84%)  
Infections and infestations      
Anogenital warts * 1    
# participants affected / at risk     4/60 (6.67%)     4/61 (6.56%)  
Bronchitis * 1    
# participants affected / at risk     8/60 (13.33%)     5/61 (8.20%)  
Gonorrhoea * 1    
# participants affected / at risk     4/60 (6.67%)     2/61 (3.28%)  
Herpes zoster * 1    
# participants affected / at risk     3/60 (5.00%)     6/61 (9.84%)  
Influenza * 1    
# participants affected / at risk     4/60 (6.67%)     6/61 (9.84%)  
Nasopharyngitis * 1    
# participants affected / at risk     3/60 (5.00%)     6/61 (9.84%)  
Sinusitis * 1    
# participants affected / at risk     10/60 (16.67%)     3/61 (4.92%)  
Tonsillitis * 1    
# participants affected / at risk     4/60 (6.67%)     0/61 (0.00%)  
Upper respiratory tract infection * 1    
# participants affected / at risk     8/60 (13.33%)     8/61 (13.11%)  
Pharyngitis * 1    
# participants affected / at risk     3/60 (5.00%)     3/61 (4.92%)  
Syphilis * 1    
# participants affected / at risk     3/60 (5.00%)     1/61 (1.64%)  
Urinary tract infection * 1    
# participants affected / at risk     3/60 (5.00%)     2/61 (3.28%)  
Investigations      
Aspartate aminotransferase increased * 1    
# participants affected / at risk     4/60 (6.67%)     1/61 (1.64%)  
Blood amylase increased * 1    
# participants affected / at risk     4/60 (6.67%)     2/61 (3.28%)  
Blood bilirubin increased * 1    
# participants affected / at risk     7/60 (11.67%)     5/61 (8.20%)  
Blood creatine phosphokinase increased * 1    
# participants affected / at risk     6/60 (10.00%)     0/61 (0.00%)  
Blood creatinine increased * 1    
# participants affected / at risk     3/60 (5.00%)     1/61 (1.64%)  
Blood uric acid increased * 1    
# participants affected / at risk     4/60 (6.67%)     0/61 (0.00%)  
Alanine aminotransferase increased * 1    
# participants affected / at risk     3/60 (5.00%)     2/61 (3.28%)  
Metabolism and nutrition disorders      
Decreased appetite * 1    
# participants affected / at risk     3/60 (5.00%)     3/61 (4.92%)  
Musculoskeletal and connective tissue disorders      
Pain in extremity * 1    
# participants affected / at risk     1/60 (1.67%)     4/61 (6.56%)  
Nervous system disorders      
Headache * 1    
# participants affected / at risk     6/60 (10.00%)     9/61 (14.75%)  
Psychiatric disorders      
Depression * 1    
# participants affected / at risk     7/60 (11.67%)     8/61 (13.11%)  
Insomnia * 1    
# participants affected / at risk     5/60 (8.33%)     4/61 (6.56%)  
Respiratory, thoracic and mediastinal disorders      
Cough * 1    
# participants affected / at risk     4/60 (6.67%)     6/61 (9.84%)  
Rhinitis allergic * 1    
# participants affected / at risk     2/60 (3.33%)     4/61 (6.56%)  
Skin and subcutaneous tissue disorders      
Rash * 1    
# participants affected / at risk     5/60 (8.33%)     4/61 (6.56%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MeDRA v14.0



  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
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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