Multicenter, Safety Study Of Maraviroc

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00478231
First received: May 22, 2007
Last updated: September 1, 2011
Last verified: September 2011
Results First Received: July 8, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Acquired Immunodeficiency Syndrome
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
A total of 638 participants were screened, out of which 429 participants were screen failures and 209 were assigned to the study treatment.

Reporting Groups
  Description
Maraviroc Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.

Participant Flow:   Overall Study
    Maraviroc  
STARTED     209  
Treated     206  
COMPLETED     125  
NOT COMPLETED     84  
Death                 7  
Lack of Efficacy                 47  
Lost to Follow-up                 7  
Withdrawal by Subject                 6  
Unspecified                 9  
Adverse Event                 5  
Randomized, not treated                 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.
No text entered.

Reporting Groups
  Description
Maraviroc Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.

Baseline Measures
    Maraviroc  
Number of Participants  
[units: participants]
  206  
Age  
[units: Years]
Mean ± Standard Deviation
  43.2  ± 7.6  
Gender  
[units: Participants]
 
Female     61  
Male     145  



  Outcome Measures
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1.  Primary:   Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline to 30 days post-week 96 or early termination (ET) ]

2.  Primary:   Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities   [ Time Frame: Baseline to 30 days post-week 96 or ET ]

3.  Primary:   Number of Participants With Treatment Emergent Malignancies   [ Time Frame: Baseline to 30 days post-week 96 or ET ]

4.  Primary:   Number of Participants With Category C Acquired Immunodeficiency Syndrome (AIDS) Related Infections   [ Time Frame: Baseline to 30 days post-week 96 or ET ]

5.  Primary:   Number of Participants With Laboratory Test Abnormalities   [ Time Frame: Baseline to 30 days post-week 96 or ET ]

6.  Secondary:   Percentage of Participants With at Least 0.5 Log 10 Reduction in Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA)   [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or end of treatment (EOT) ]

7.  Secondary:   Percentage of Participants With at Least 1.0 Log 10 Reduction in HIV-1 RNA   [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT ]

8.  Secondary:   Percentage of Participants Achieving HIV-1 RNA Below Limit of Quantification   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT ]

9.  Secondary:   Change From Baseline in Lymphocyte Cluster of Differentiation 4 (CD4) Count at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT ]

10.  Secondary:   Change From Baseline in Lymphocyte Cluster of Differentiation 8 (CD8) Count at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT ]

11.  Secondary:   Change From Baseline in CD4 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT ]

12.  Secondary:   Change From Baseline in CD8 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT ]

13.  Secondary:   Number of Participants With C-X-C Chemokine Receptor Type 4 {CXCR4} [X4] Tropism Status   [ Time Frame: Time of virologic failure (VF) and Week 96 or EOT ]

14.  Other Pre-specified:   Change From Baseline in Human Immunodeficiency Virus (HIV) -1 Viral Load (Ribonucleic Acid [RNA]) at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT ]

15.  Other Pre-specified:   Time to Virologic Failure (VF)   [ Time Frame: Baseline to Week 96 or EOT ]

16.  Other Pre-specified:   Number of Participants With Genotype Resistance   [ Time Frame: Baseline through Week 96 ]


  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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  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 by ViiV Healthcare

Publications automatically indexed to this study:

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00478231     History of Changes
Other Study ID Numbers: A4001063
Study First Received: May 22, 2007
Results First Received: July 8, 2011
Last Updated: September 1, 2011
Health Authority: Brazil: National Ethics Committee (CONEP)