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

History of Changes

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

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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

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.
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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
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 ]

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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 ]

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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 ]

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4. Primary:

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

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5. Primary:

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

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6. Primary:

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

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7. Primary:

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

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8. Primary:

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

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9. Primary:

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

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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 ]

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11. Secondary:

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

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12. Secondary:

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

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13. Secondary:

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

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Serious Adverse Events

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