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

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ClinicalTrials.gov Identifier: NCT00850395
Recruitment Status : Completed
First Posted : February 25, 2009
Results First Posted : October 15, 2012
Last Update Posted : November 7, 2012
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare

Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: HIV-1
Intervention: Drug: maraviroc

  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 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

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

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 ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 2

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 ]
  Show Outcome Measure 3

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

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

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

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

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

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

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 ]
  Show Outcome Measure 10

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

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

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


  Serious Adverse Events


  Other Adverse Events


  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
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