Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects (MOTIVATE 2)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00098722
First received: December 7, 2004
Last updated: April 16, 2012
Last verified: April 2012
Results First Received: April 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Maraviroc (UK-427,857)
Drug: optimized background therapy

  Participant Flow


  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 QD Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, 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 (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
Maraviroc BID Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Placebo Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Total Total of all reporting groups

Baseline Measures
    Maraviroc QD     Maraviroc BID     Placebo     Total  
Number of Participants  
[units: participants]
  182     191     91     464  
Age, Customized [1]
[units: participants]
       
Less than 18 years     1     0     0     1  
18 to 24 years     1     1     0     2  
25 to 34 years     8     9     6     23  
35 to 44 years     85     71     40     196  
45 to 54 years     63     70     32     165  
55 to 64 years     19     37     11     67  
Greater than or equal to 65 years     5     3     2     10  
Gender [2]
[units: participants]
       
Female     29     21     12     62  
Male     153     170     79     402  
[1] Out of a total of 474 participants, data for baseline measure (age) was available for 464 participants who were treated.
[2] Out of a total of 474 participants, data for baseline measure (gender) was available for 464 participants who were treated.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline   [ Time Frame: Baseline ]

2.  Primary:   Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 24   [ Time Frame: Baseline and Week 24 ]

3.  Primary:   Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 48   [ Time Frame: Baseline and Week 48 ]

4.  Secondary:   Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL   [ Time Frame: Week 24 and 48 ]

5.  Secondary:   Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 0.5 log10 Decrease From Baseline   [ Time Frame: Week 24 and 48 ]

6.  Secondary:   Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 1.0 log10 Decrease From Baseline   [ Time Frame: Week 24 and 48 ]

7.  Secondary:   Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL   [ Time Frame: Week 24 and 48 ]

8.  Secondary:   Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline   [ Time Frame: Baseline ]

9.  Secondary:   Change From Baseline in CD4 Cell Count at Week 24 and 48   [ Time Frame: Week 24 and 48 ]

10.  Secondary:   Change From Baseline in CD8 Cell Count at Week 24 and 48   [ Time Frame: Week 24 and 48 ]

11.  Secondary:   Time to Virological Failure   [ Time Frame: Week 48 ]

12.  Secondary:   Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels   [ Time Frame: Baseline to Week 24 and Week 48 ]

13.  Secondary:   Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening   [ Time Frame: Screening ]

14.  Secondary:   Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24   [ Time Frame: Screening and time of failure through Week 24 ]

15.  Secondary:   Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48   [ Time Frame: Screening and time of failure through Week 48 ]

16.  Secondary:   Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24   [ Time Frame: Baseline and time of failure through Week 24 ]

17.  Secondary:   Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48   [ Time Frame: Baseline and time of failure through Week 48 ]

18.  Secondary:   Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening   [ Time Frame: Baseline, Week 24 and Week 48 ]


  Serious Adverse Events


  Other Adverse Events


  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 by ViiV Healthcare

Publications automatically indexed to this study:

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00098722     History of Changes
Other Study ID Numbers: A4001028
Study First Received: December 7, 2004
Results First Received: April 16, 2012
Last Updated: April 16, 2012
Health Authority: United States: Food and Drug Administration