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

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
Unspecified	5

Baseline Characteristics

Hide Baseline Characteristics

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

Show All 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

Show Serious Adverse Events

Other Adverse Events

Hide Other Adverse Events

Time Frame	No text entered.
Additional Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Frequency Threshold

Threshold above which other adverse events are reported	5%

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.

Other Adverse Events

	Maraviroc
Total, other (not including serious) adverse events
# participants affected / at risk	4/79
Infections and infestations
Bronchitis ^{* 1}
# participants affected / at risk	4/79 (5.06%)

*	Events were collected by non-systematic assessment
1	Term from vocabulary, MedDRA 14.1

More Information

Hide More Information

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