Multicenter Pilot Study To Define The Marker As An Alternate For Tropism Assay

This study has been terminated.
(See Detailed Description)
Sponsor:
Collaborator:
Pfizer
Information provided by:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00496782
First received: July 3, 2007
Last updated: November 10, 2010
Last verified: March 2010
Results First Received: June 23, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Screening
Condition: HIV Infections
Interventions: Drug: maraviroc
Procedure: Trofile Assay and HIV RNA quantification assay

  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
CCR5-Tropic HIV-1 Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
Non-CCR5-Tropic HIV-1 Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.

Participant Flow:   Overall Study
    CCR5-Tropic HIV-1     Non-CCR5-Tropic HIV-1  
STARTED     9     7  
COMPLETED     8     5  
NOT COMPLETED     1     2  
Protocol Violation                 1                 2  



  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
CCR5-Tropic HIV-1 Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
Non-CCR5-Tropic HIV-1 Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
Total Total of all reporting groups

Baseline Measures
    CCR5-Tropic HIV-1     Non-CCR5-Tropic HIV-1     Total  
Number of Participants  
[units: participants]
  9     7     16  
Age  
[units: years]
Mean ± Standard Deviation
  46.3  ± 4.9     41.0  ± 4.8     44.0  ± 5.4  
Gender  
[units: participants]
     
Female     1     1     2  
Male     8     6     14  



  Outcome Measures
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1.  Primary:   Change From Baseline in Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) With R5 & Non-R5 Tropism Results From the Trofile(tm) Assay   [ Time Frame: Baseline, Day 4, 7, 14 ]

2.  Secondary:   Subjects Achieving HIV-1 RNA <400 Copies/mL   [ Time Frame: Days 4, 7, 14, 28, and Weeks 8, 12, 18, and 24 ]

3.  Secondary:   Subjects Achieving HIV-1 RNA <50 Copies/mL   [ Time Frame: Days 4, 7, 14, 28, and Weeks 8, 12, 18, and 24 ]

4.  Secondary:   Subjects With Virologic Failure   [ Time Frame: Baseline up to Week 24 ]

5.  Secondary:   Time to Virologic Failure   [ Time Frame: Baseline up to Week 24 ]

6.  Secondary:   Change in Lymphocyte Subset CD4 From Baseline   [ Time Frame: Day 1 (Baseline), Day 7, 14, 28 and Weeks 24 ]

7.  Secondary:   Change in Lymphocyte Subset CD8 From Day 1   [ Time Frame: Day 1(Baseline), Day 7, 14, 28 and Weeks 24 ]

8.  Secondary:   Change in Lymphocyte Subsets; CD4 and CD8 From Screening.   [ Time Frame: Screening (Day -14 to 0), Day 1. ]

9.  Secondary:   Change in Detectable Tropism From Screening   [ Time Frame: Screening (Day -21 to 0), Baseline. ]

10.  Secondary:   Change in Detectable Tropism From Baseline   [ Time Frame: Baseline, Day 15 and Week 24/End of Study/Discontinuation ]

11.  Secondary:   Change in Detectable Resistance (Genotype) and Susceptibility (Phenotype) to Drugs in the Regimen From Screening   [ Time Frame: Screening (Day -21), Baseline (Day 0), Day 14 (after addition of MVC to a failing regimen), Week 24, and time of Virologic Failure. ]

12.  Secondary:   Number of Subjects With Susceptibility to Maraviroc   [ Time Frame: Screening (Day -21 to 0), Day 14, Week 24 ]

13.  Secondary:   Change in Gene Sequence in Gp-160, and the V3 Loop From Screening Visit (Day -21 to 0) to Day 14, Time of Virologic Failure (See Section 6.5.1) and Week 24   [ Time Frame: Screening (Day -21 to 0), Day 14, time of virologic failure, and Week 24 ]

14.  Secondary:   Correlation of Mutations in gp160 and the V3 Loop and Decreased Susceptibility to Maraviroc   [ Time Frame: Screening (Day -21 to 0), Day 14, time of virologic failure, Week 24 ]


  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
Study terminated prematurely due to slow enrollment. Premature termination of study was not due to any safety concerns. Efficacy data not summarized due to low sample size; only safety was summarized.


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


No publications provided


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00496782     History of Changes
Other Study ID Numbers: A4001060
Study First Received: July 3, 2007
Results First Received: June 23, 2009
Last Updated: November 10, 2010
Health Authority: United States: Food and Drug Administration