Expanded Access Program for Maraviroc At Multiple Centers

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00426660
First received: January 22, 2007
Last updated: September 12, 2011
Last verified: September 2011
Results First Received: June 2, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Advanced HIV Infection
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
Of 2584 participants screened, 1047 participants were enrolled in the study.

Reporting Groups
  Description
Maraviroc Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.

Participant Flow:   Overall Study
    Maraviroc  
STARTED     1047  
Treated     1032  
Safety Analysis Set     1032  
COMPLETED     916  
NOT COMPLETED     131  
Death                 14  
Adverse Event                 23  
Insufficient Clinical Response                 22  
Lost to Follow-up                 15  
Unspecified                 23  
Withdrawal by Subject                 18  
Protocol Violation                 1  
Enrolled Not Treated                 15  



  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 Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.

Baseline Measures
    Maraviroc  
Number of Participants  
[units: participants]
  1032  
Age  
[units: years]
Mean ± Standard Deviation
  45.6  ± 8.6  
Gender  
[units: participants]
 
Female     205  
Male     827  
Baseline Viral Load: Absolute Value [1]
[units: copies/mL]
Mean ± Standard Deviation
 
Overall: Absolute (N=979)     117846.1  ± 321426.5  
< 100,000: Absolute (N=729)     22395.9  ± 25974.4  
>= 100,000: Absolute (N=250)     396179.0  ± 547142.6  
Baseline Viral Load: Absolute Value [2]
[units: copies/mL]
Median ( Full Range )
 
Overall: Absolute (N=979)     25109.5  
  ( 39.0 to 5728492.0 )  
< 100,000: Absolute (N=729)     11028.5  
  ( 39.0 to 99643.0 )  
>= 100,000: Absolute (N=250)     234750.0  
  ( 100000.0 to 5728492.0 )  
Baseline Viral Load: Log Scale [3]
[units: log10┬ácopies/mL]
Mean ± Standard Deviation
 
Overall: Log Scale (N=979)     4.259  ± 1.0182  
< 100,000: Log Scale (N=729)     3.859  ± 0.8517  
>= 100,000: Log Scale (N=250)     5.423  ± 0.3496  
Baseline Viral Load: : Log Scale [3]
[units: log10┬ácopies/mL]
Median ( Full Range )
 
Overall: Log Scale (N=979)     4.400  
  ( 1.591 to 6.758 )  
< 100,000: Log Scale (N=729)     4.043  
  ( 1.591 to 4.998 )  
>= 100,000: Log Scale (N=250)     5.371  
  ( 5.000 to 6.758 )  
[1] Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) at baseline (BL) (original scale). BL value calculated as average of screening and BL values if both values were within 1 log10 difference. N = number of participants contributing to summary statistic at BL. Viral loads were not available uniformly for all participants enrolled in study.
[2] HIV-1 RNA at baseline (BL)(original scale). BL value calculated as average of screening and BL values if both values were within 1 log10 difference. N = number of participants contributing to summary statistic at BL. Viral loads were not available uniformly for all participants enrolled in study.
[3] HIV-1 RNA at baseline (BL)(log10 copies/mL). BL value calculated as average of screening and BL values if both values were within 1 log10 difference. N = number of participants contributing to summary statistic at BL. Viral loads were not available uniformly for all participants enrolled in study.



  Outcome Measures
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1.  Primary:   Percentage of Participants With Grade 3 and Grade 4 Adverse Events (AE)   [ Time Frame: Baseline up to Week 144 ]

2.  Primary:   Percentage of Participants With Grade 3 Laboratory Abnormalities Without Regards to Baseline Abnormalities   [ Time Frame: Baseline up to Week 144 ]

3.  Primary:   Percentage of Participants With Grade 4 Laboratory Abnormalities Without Regards to Baseline Abnormalities   [ Time Frame: Baseline up to Week 144 ]

4.  Primary:   Percentage of Participants With Acquired Immunodeficiency Syndrome (AIDS)-Defining Illnesses   [ Time Frame: Baseline up to Week 144 ]

5.  Primary:   Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline Viral Load   [ Time Frame: Baseline up to Week 144 ]

6.  Primary:   Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline/Nadir CD4 Cell Counts   [ Time Frame: Baseline up to Week 144 ]

7.  Primary:   Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Time on Therapy   [ Time Frame: Baseline up to Week 144 ]

8.  Primary:   Percentage of Participants With All Causality Treatment-emergent Adverse (AEs) Events by Gender   [ Time Frame: Baseline up to Week 144 ]

9.  Primary:   Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Race   [ Time Frame: Baseline up to Week 144 ]

10.  Primary:   Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Age   [ Time Frame: Baseline up to Week 144 ]

11.  Primary:   Percentage of Participants With Treatment-emergent Averse Events (AEs) by Baseline Hepatitis B and Hepatitis C Virus Serology Status   [ Time Frame: Baseline up to Week 144 ]

12.  Secondary:   Percentage of Participants With ≥0.5 log10 Reduction From Baseline in Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV 1 RNA)   [ Time Frame: Baseline up to Week 144 ]

13.  Secondary:   Percentage of Participants With ≥1.0 log10 Reduction From Baseline in HIV 1 RNA   [ Time Frame: Baseline up to Week 144 ]

14.  Secondary:   Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <400 Copies/mL   [ Time Frame: Baseline up to Week 144 ]

15.  Secondary:   Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <50 Copies/mL   [ Time Frame: Baseline up to Week 144 ]

16.  Secondary:   Change From Baseline in CD4 Cell Count   [ Time Frame: Baseline up to Week 144 ]

17.  Secondary:   Change From Baseline in CD4 Cell Count Percent   [ Time Frame: Baseline up to Week 144 ]

18.  Secondary:   Change From Baseline in CD8 Cell Count   [ Time Frame: Baseline up to Week 144 ]

19.  Secondary:   Change From Baseline in CD8 Cell Count Percent   [ Time Frame: Baseline up to Week 144 ]

20.  Secondary:   Median Time to Virologic Failure   [ Time Frame: Day 1 up to Week 144 ]

21.  Secondary:   Percentage of Participants With Changes in HIV-1 RNA Level in Participants Meeting the Definition of Virologic Failure   [ Time Frame: Baseline up to Week 144 ]

22.  Secondary:   Percentage of Participants With Change in Chemokine Co-receptor Tropism From Screening to Time of Virologic Failure   [ Time Frame: Screening up to Week 144 ]

23.  Secondary:   Emergence of Resistance to Maraviroc   [ Time Frame: Baseline up to Week 144 ]
Results not yet posted.   Anticipated Posting Date:   12/2011   Safety Issue:   No


  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
Viral loads were not available for subjects uniformly as this expanded access study followed local country guidelines and practices that could vary significantly between countries, and testing frequency may have been affected by insurance status.


  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.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00426660     History of Changes
Other Study ID Numbers: A4001050
Study First Received: January 22, 2007
Results First Received: June 2, 2011
Last Updated: September 12, 2011
Health Authority: United States: Food and Drug Administration