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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 1)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00098306
First received: December 6, 2004
Last updated: April 2, 2012
Last verified: April 2012
Results First Received: April 2, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Maraviroc (UK-427,857)
Drug: Optimized Background Therapy
Drug: Placebo

  Participant Flow
  Hide Participant Flow

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
Maraviroc QD, Double Blind 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, Double Blind 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, Double Blind 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).
Maraviroc BID, Open Label Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received maraviroc 150 or 300 mg 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) during open label phase.
In Study-off Drug (ISOD), Open Label Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) in during open label phase.
Maraviroc BID, Observation Phase Participants continuing from open label phase, who received maraviroc 150 or 300 mg 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) during observational phase.
In Study-off Drug (ISOD), Observation Phase Participants continuing from open label phase, who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.

Participant Flow for 3 periods

Period 1:   Double Blind
    Maraviroc QD, Double Blind   Maraviroc BID, Double Blind   Placebo, Double Blind   Maraviroc BID, Open Label   In Study-off Drug (ISOD), Open Label   Maraviroc BID, Observation Phase   In Study-off Drug (ISOD), Observation Phase
STARTED   241   240   120   0   0   0   0 
Treated   232   235   118   0   0   0   0 
COMPLETED   0   0   0   0   0   0   0 
NOT COMPLETED   241   240   120   0   0   0   0 
Randomized, not treated                9                5                2                0                0                0                0 
Ongoing at cut-off date                151                166                72                0                0                0                0 
Adverse Event                11                10                6                0                0                0                0 
Lack of Efficacy                43                34                17                0                0                0                0 
Death                1                4                1                0                0                0                0 
Participant defaulted                19                18                11                0                0                0                0 
Un-specified                7                3                11                0                0                0                0 

Period 2:   Open Label
    Maraviroc QD, Double Blind   Maraviroc BID, Double Blind   Placebo, Double Blind   Maraviroc BID, Open Label   In Study-off Drug (ISOD), Open Label   Maraviroc BID, Observation Phase   In Study-off Drug (ISOD), Observation Phase
STARTED   0   0   0   327   62   0   0 
COMPLETED   0   0   0   0   0   0   0 
NOT COMPLETED   0   0   0   327   62   0   0 
Lack of Efficacy                0                0                0                13                0                0                0 
Adverse Event                0                0                0                2                0                0                0 
Death                0                0                0                4                0                0                0 
Participant defaulted                0                0                0                24                0                0                0 
Un-specified                0                0                0                15                0                0                0 
Ongoing at cut-off date                0                0                0                269                62                0                0 

Period 3:   Observational Phase
    Maraviroc QD, Double Blind   Maraviroc BID, Double Blind   Placebo, Double Blind   Maraviroc BID, Open Label   In Study-off Drug (ISOD), Open Label   Maraviroc BID, Observation Phase   In Study-off Drug (ISOD), Observation Phase
STARTED   0   0   0   0   0   250   81 
COMPLETED   0   0   0   0   0   204   55 
NOT COMPLETED   0   0   0   0   0   46   26 
Death                0                0                0                0                0                5                4 
Participant defaulted                0                0                0                0                0                34                18 
Un-specified                0                0                0                0                0                7                4 



  Baseline Characteristics
  Hide Baseline Characteristics

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 (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 
Overall Participants Analyzed 
[Units: Participants]
 232   235   118   585 
Age, Customized [1] 
[Units: Participants]
       
Less than 18 years   0   0   0   0 
18 to 24 years   1   0   0   1 
25 to 34 years   10   7   5   22 
35 to 44 years   97   108   48   253 
45 to 54 years   93   90   45   228 
55 to 64 years   26   28   19   73 
Greater than or equal to 65 years   5   2   1   8 
[1] Out of a total of 601 participants, data for baseline measure (age) was available for 585 participants who were treated.
Gender [1] 
[Units: Participants]
       
Female   22   23   12   57 
Male   210   212   106   528 
[1] Out of a total of 601 participants, data for baseline measure (gender) was available for 585 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: Baseline, Week 24 and 48 ]

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


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00098306     History of Changes
Other Study ID Numbers: A4001027
Study First Received: December 6, 2004
Results First Received: April 2, 2012
Last Updated: April 2, 2012