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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

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.
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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.

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 ]

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 ]

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.