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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00850395
First received: February 23, 2009
Last updated: November 5, 2012
Last verified: November 2012
Results First Received: 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  
Unspecified                 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  
Number of Participants  
[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  
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 [2]
[units: participants]
 
Category A     31  
Category B     21  
Category C     27  
Acquired Immune Deficiency Syndrome Clinical Trials Group Symptom Distress Module(SDM) Overall Score [3]
[units: units on a scale]
Mean ± Standard Deviation
  17.37  ± 14.026  
[1] Number of participants evaluable for this measure=78.
[2] Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).
[3] 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
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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 ]

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 ]
  Hide Outcome Measure 10

Measure Type Secondary
Measure Title Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Overall Score at Months 6 and 12
Measure Description SDM consists of the 20 items questionnaire, each item rated from 0 to 4 where 0 (complete absence of symptom) and 4 (very bothersome symptom). Overall score calculated as the sum of the scores for each of the 20 items of the questionnaire and ranged from 0 (best health) and 80 (worst health). A positive change from baseline indicates a decline in a participant’s quality of life over that period.
Time Frame Baseline, Months 6, 12  
Safety Issue No  

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. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants evaluable at specified time point. Missing values were imputed only for Month 12 as zero for those participants who either discontinued prematurely before the final visit or had missing baseline measurements.

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  
Number of Participants Analyzed  
[units: participants]
  79  
Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Overall Score at Months 6 and 12  
[units: units on a scale]
Mean ± Standard Deviation
 
Change at Month 6 (n=51)     -4.87  ± 12.527  
Change at Month 12 (n=79)     -2.14  ± 11.728  

No statistical analysis provided for Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Overall Score at Months 6 and 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


No publications provided


Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00850395     History of Changes
Other Study ID Numbers: A4001070, CELTROP
Study First Received: February 23, 2009
Results First Received: September 11, 2012
Last Updated: November 5, 2012
Health Authority: Germany: BfArM