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Non-Interventional Study Of Celsentri® In Treatment Experienced Patients With CCR5-Tropic HIV-Infection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00850395
First Posted: February 25, 2009
Last Update Posted: November 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
Results First Submitted: September 11, 2012  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: HIV-1
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
No text entered.

Reporting Groups
  Description
Maraviroc Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.

Participant Flow:   Overall Study
    Maraviroc
STARTED   79 
COMPLETED   69 
NOT COMPLETED   10 
Death                1 
Adverse Event                1 
Insufficient clinical response                3 
Other                5 



  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 Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.

Baseline Measures
   Maraviroc 
Overall Participants Analyzed 
[Units: Participants]
 79 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.1  (11.2) 
Gender 
[Units: Participants]
 
Female   12 
Male   67 
Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) [1] 
[Units: Copies/milliliter (copies/mL)]
Mean (Standard Deviation)
 3.01  (1.599) 
[1] Number of participants evaluable for this measure=78.
Cluster of Differentiation 4 (CD4+) Cell Counts 
[Units: Cells/microliter (cells/mcL)]
Mean (Standard Deviation)
 458.8  (250.14) 
Number of Participants With Centers for Disease Control and Prevention (CDC) Classification [1] 
[Units: Participants]
 
Category A   31 
Category B   21 
Category C   27 
[1] Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).
Acquired Immune Deficiency Syndrome Clinical Trials Group Symptom Distress Module(SDM) Overall Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 17.37  (14.026) 
[1] SDM: 20 items questionnaire, each item rated from 0 to 4, 0=complete absence of symptom and 4=very bothersome symptom. Overall score: sum of scores for each of 20 items of questionnaire, with 0=best health and 80=worst health. A positive change from baseline indicates decline in participant’s quality of life. Number of participants evaluable=55.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3   [ Time Frame: Baseline, Month 3 ]

2.  Primary:   Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 6   [ Time Frame: Baseline, Month 6 ]
  Hide Outcome Measure 2

Measure Type Primary
Measure Title Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 6
Measure Description No text entered.
Time Frame Baseline, Month 6  

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.
FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Reporting Groups
  Description
Maraviroc Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.

Measured Values
   Maraviroc 
Participants Analyzed 
[Units: Participants]
 74 
Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 6 
[Units: copies/mL]
Mean (Standard Deviation)
 -1.15  (1.579) 

No statistical analysis provided for Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 6



3.  Primary:   Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 12   [ Time Frame: Baseline, Month 12 ]

4.  Primary:   Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 3   [ Time Frame: Baseline, Month 3 ]

5.  Primary:   Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 6   [ Time Frame: Baseline, Month 6 ]

6.  Primary:   Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 12   [ Time Frame: Baseline, Month 12 ]

7.  Primary:   Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 3   [ Time Frame: Month 3 ]

8.  Primary:   Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 6   [ Time Frame: Month 6 ]

9.  Primary:   Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 12   [ Time Frame: Month 12 ]

10.  Secondary:   Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Overall Score at Months 6 and 12   [ Time Frame: Baseline, Months 6, 12 ]

11.  Secondary:   Number of Participants With Human Immunodeficiency Virus (HIV) Response   [ Time Frame: Month 12 ]

12.  Secondary:   Physician's Assessment of Efficacy   [ Time Frame: Month 12 ]

13.  Secondary:   Number of Participants Taking Concomitant Therapy   [ Time Frame: Baseline, Month 12 ]


  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
Designation of outcomes as primary and secondary was based on study team input as study did not specify primary or secondary outcome measures.


  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



Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00850395     History of Changes
Other Study ID Numbers: A4001070
CELTROP
First Submitted: February 23, 2009
First Posted: February 25, 2009
Results First Submitted: September 11, 2012
Results First Posted: October 15, 2012
Last Update Posted: November 7, 2012