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

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

Baseline Characteristics

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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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Measure Type	Primary
Measure Title	Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 3
Measure Description	No text entered.
Time Frame	Baseline, Month 3
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 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
Number of Participants Analyzed [units: participants]	75
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 3 [units: cells/mcL] Mean ± Standard Deviation	74.31 ± 162.18

No statistical analysis provided for Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 3

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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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

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.

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

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