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

• Sponsor: ViiV Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00850395
• Collaborator: Pfizer (Industry)
• Enrollment: 79
• Duration (Months): 27

Study Details

Study Description

Brief Summary

Aim of the study is to gain more knowledge about efficacy of CELSENTRI® in daily clinical practice and obtain information about the quality of life of patients using CELSENTRI®.

Condition or Disease	Intervention/Treatment	Phase
HIV-1	Drug: maraviroc

Detailed Description

Non interventional study, inclusion and exclusion criteria defined by the labelling of Celsentri (Maraviroc).

Study Design

• Study Type: Observational
• Actual Enrollment: 79 participants
• Time Perspective: Prospective
• Official Title: Non-Interventional Study Of Celsentri® In Treatment Experienced Patients Infected With CCR5 Tropic HIV-1
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
1 Non-Interventional	Drug: maraviroc; No intervention; any procedure at the discretion of the treating physician, in line with the SmPC; Other Names: Selzentry, Celsentri

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3 [Baseline, Month 3]

2. Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 6 [Baseline, Month 6]

3. Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 12 [Baseline, Month 12]

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

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

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

7. Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 3 [Month 3]

   Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).

8. Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 6 [Month 6]

   Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).

9. Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 12 [Month 12]

   Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).

Secondary Outcome Measures

1. Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Overall Score at Months 6 and 12 [Baseline, Months 6, 12]

   SDM consists of the 20 items questionnaire, each item rated from 0 to 4 where 0 (complete absence of symptom) and 4 (very bothersome symptom). Overall score calculated as the sum of the scores for each of the 20 items of the questionnaire and ranged from 0 (best health) and 80 (worst health). A positive change from baseline indicates a decline in a participant's quality of life over that period.

2. Number of Participants With Human Immunodeficiency Virus (HIV) Response [Month 12]

   Response was defined as a HIV-1 RNA count of less than 50 copies/mL.

3. Physician's Assessment of Efficacy [Month 12]

   Number of participants with each grade of efficacy as assessed by the physician was reported on the 5 point categorical scale: excellent, very good, good, fair, poor.

4. Number of Participants Taking Concomitant Therapy [Baseline, Month 12]

   Participants taking HIV/AIDS concomitant medication at Month 12, at Baseline and Month 12 were reported. It included Emtricitabine/tenofovir disoproxil fumarate(FTC/TDF),Raltegravir(RAL), Ritonavir (RTV), Darunavir(DRV), Kaletra, Atazanavir sulfate(ATV), Abacavir sulfate/lamivudine(ABC/LAM), Tenofovir disoproxil fumarate(TDF), Etravirine(ETR), Lamivudine (LAM), Zidovudine W/lamivudine(ZDV W/LAM), Nevirapine(NVP), Saquinavir mesilate(SQV), Trizivir(TZV), Zidovudine(ZDV), Abacavir sulfate(ABC), Emtricitabine(FTC),Entecavir(ETV).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

HIV-1 infection. CCR-5 tropic virus. Therapy experienced patient,

Exclusion Criteria:

X4 or D/M tropic virus. Therapy-naive patients.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• ViiV Healthcare
• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: ViiV Healthcare
• ClinicalTrials.gov Identifier: NCT00850395
• Other Study ID Numbers: A4001070; CELTROP
• First Posted: Feb 25, 2009
• Last Update Posted: Nov 7, 2012
• Last Verified: Nov 1, 2012

• Keywords provided by ViiV Healthcare: HIV-1; non-interventional; CCR-5 tropic virus; therapy experienced patients
• Additional relevant MeSH terms: Maraviroc

Study Results

Participant Flow

Arm/Group Title	Maraviroc
Arm/Group Description	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.
Period Title: Overall Study
STARTED	79
COMPLETED	69
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	Maraviroc
Arm/Group Description	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.
Overall Participants	79
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.1 (11.2)
Sex: Female, Male (Count of Participants)
Female	12 15.2%
Male	67 84.8%
Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) (copies/milliliter (copies/mL)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [copies/milliliter (copies/mL)]	3.01 (1.599)
Cluster of Differentiation 4 (CD4+) Cell Counts (cells/microliter (cells/mcL)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cells/microliter (cells/mcL)]	458.8 (250.14)
Number of Participants With Centers for Disease Control and Prevention (CDC) Classification (participants) [Number]
Category A	31 39.2%
Category B	21 26.6%
Category C	27 34.2%
Acquired Immune Deficiency Syndrome Clinical Trials Group Symptom Distress Module(SDM) Overall Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	17.37 (14.026)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3
Time Frame	Baseline, Month 3

Outcome Measure Data

Analysis Population Description

Full Analysis Set (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.

Arm/Group Title	Maraviroc
Arm/Group Description	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.
Measure Participants	75
Mean (Standard Deviation) [copies/mL]	-1.10 (1.530)

2. Primary Outcome

Title	Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 6
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Maraviroc
Arm/Group Description	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.
Measure Participants	74
Mean (Standard Deviation) [copies/mL]	-1.15 (1.579)

3. Primary Outcome

Title	Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 12
Time Frame	Baseline, Month 12

Outcome Measure Data

Analysis Population Description

FAS population included all participants who received at least one dose (including partial doses) of study medication. Missing values were imputed as zero for those participants who either discontinued prematurely before the final visit or had missing baseline measurements.

Arm/Group Title	Maraviroc
Arm/Group Description	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.
Measure Participants	79
Mean (Standard Deviation) [copies/mL]	-0.95 (1.571)

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Maraviroc
Arm/Group Description	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.
Measure Participants	75
Mean (Standard Deviation) [cells/mcL]	74.31 (162.18)

5. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Maraviroc
Arm/Group Description	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.
Measure Participants	75
Mean (Standard Deviation) [cells/mcL]	91.88 (168.43)

6. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

FAS population included all participants who received at least one dose (including partial doses) of study medication. Missing values were imputed as zero for those participants who either discontinued prematurely before the final visit or had missing baseline measurements.

Arm/Group Title	Maraviroc
Arm/Group Description	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.
Measure Participants	79
Mean (Standard Deviation) [cells/mcL]	97.57 (237.70)

7. Primary Outcome

Title	Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 3
Description	Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).
Time Frame	Month 3

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Maraviroc
Arm/Group Description	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.
Measure Participants	76
Category A	31 39.2%
Category B	19 24.1%
Category C	26 32.9%

8. Primary Outcome

Title	Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 6
Description	Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Maraviroc
Arm/Group Description	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.
Measure Participants	74
Category A	31 39.2%
Category B	16 20.3%
Category C	27 34.2%

9. Primary Outcome

Title	Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 12
Description	Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

FAS population included all participants who received at least one dose (including partial doses) of study medication. Missing values were imputed as zero for those participants who either discontinued prematurely before the final visit or had missing baseline measurements.

Arm/Group Title	Maraviroc
Arm/Group Description	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.
Measure Participants	79
Category A	31 39.2%
Category B	20 25.3%
Category C	28 35.4%

10. Secondary Outcome

Title	Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Overall Score at Months 6 and 12
Description	SDM consists of the 20 items questionnaire, each item rated from 0 to 4 where 0 (complete absence of symptom) and 4 (very bothersome symptom). Overall score calculated as the sum of the scores for each of the 20 items of the questionnaire and ranged from 0 (best health) and 80 (worst health). A positive change from baseline indicates a decline in a participant's quality of life over that period.
Time Frame	Baseline, Months 6, 12

Outcome Measure Data

Analysis Population Description

FAS population. 'N' (number of participants analyzed) signifies participants evaluable for this measure. 'n' signifies participants evaluable at specified time point. Missing values were imputed only for Month 12 as zero for those participants who either discontinued prematurely before the final visit or had missing baseline measurements.

Arm/Group Title	Maraviroc
Arm/Group Description	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.
Measure Participants	79
Change at Month 6 (n=51)	-4.87 (12.527)
Change at Month 12 (n=79)	-2.14 (11.728)

11. Secondary Outcome

Title	Number of Participants With Human Immunodeficiency Virus (HIV) Response
Description	Response was defined as a HIV-1 RNA count of less than 50 copies/mL.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

FAS population included all participants who received at least one dose (including partial doses) of study medication.

Arm/Group Title	Maraviroc
Arm/Group Description	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.
Measure Participants	79
Number [participants]	51 64.6%

12. Secondary Outcome

Title	Physician's Assessment of Efficacy
Description	Number of participants with each grade of efficacy as assessed by the physician was reported on the 5 point categorical scale: excellent, very good, good, fair, poor.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

FAS population included all participants who received at least one dose (including partial doses) of study medication.

Arm/Group Title	Maraviroc
Arm/Group Description	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.
Measure Participants	79
Excellent	15 19%
Very Good	42 53.2%
Good	14 17.7%
Fair	1 1.3%
Poor	1 1.3%

13. Secondary Outcome

Title	Number of Participants Taking Concomitant Therapy
Description	Participants taking HIV/AIDS concomitant medication at Month 12, at Baseline and Month 12 were reported. It included Emtricitabine/tenofovir disoproxil fumarate(FTC/TDF),Raltegravir(RAL), Ritonavir (RTV), Darunavir(DRV), Kaletra, Atazanavir sulfate(ATV), Abacavir sulfate/lamivudine(ABC/LAM), Tenofovir disoproxil fumarate(TDF), Etravirine(ETR), Lamivudine (LAM), Zidovudine W/lamivudine(ZDV W/LAM), Nevirapine(NVP), Saquinavir mesilate(SQV), Trizivir(TZV), Zidovudine(ZDV), Abacavir sulfate(ABC), Emtricitabine(FTC),Entecavir(ETV).
Time Frame	Baseline, Month 12

Outcome Measure Data

Analysis Population Description

FAS population included all participants who received at least one dose (including partial doses) of study medication.

Arm/Group Title	Maraviroc
Arm/Group Description	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.
Measure Participants	79
ABC, FTC/TDF (Month 12)	1 1.3%
ABC, FTC/TDF (Baseline, Month 12)	1 1.3%
ABC/LAM (Month 12)	2 2.5%
ABC/LAM (Baseline, Month 12)	2 2.5%
ABC/LAM, DRV, RAL (Month 12)	1 1.3%
ABC/LAM, DRV, RAL (Baseline, Month 12)	0 0%
ABC/LAM, RAL (Month 12)	2 2.5%
ABC/LAM, RAL (Baseline, Month 12)	2 2.5%
ABC/LAM, RAL, TDF (Month 12)	1 1.3%
ABC/LAM, RAL, TDF (Baseline, Month 12)	1 1.3%
ATV (Month 12)	1 1.3%
ATV (Baseline, Month 12)	1 1.3%
ATV, FTC/TDF (Month 12)	1 1.3%
ATV, FTC/TDF (Baseline, Month 12)	1 1.3%
ATV, FTC/TDF, RTV (Month 12)	1 1.3%
ATV, FTC/TDF, RTV (Baseline, Month 12)	1 1.3%
ATV, LAM, RAL, RTV (Month 12)	1 1.3%
ATV, LAM, RAL, RTV (Baseline, Month 12)	0 0%
ATV, RAL (Month 12)	2 2.5%
ATV, RAL (Baseline, Month 12)	2 2.5%
ATV, RAL, RTV (Month 12)	1 1.3%
ATV, RAL, RTV (Baseline, Month 12)	1 1.3%
ATV, RTV (Month 12)	1 1.3%
ATV, RTV (Baseline, Month 12)	1 1.3%
DRV, FTC/TDF (Month 12)	1 1.3%
DRV, FTC/TDF (Baseline, Month 12)	1 1.3%
DRV, FTC/TDF, ETR (Month 12)	1 1.3%
DRV, FTC/TDF, ETR (Baseline, Month 12)	1 1.3%
DRV, FTC/TDF, RTV (Month 12)	6 7.6%
DRV, FTC/TDF, RTV (Baseline, Month 12)	5 6.3%
DRV, ETV, ETR, RTV (Month 12)	1 1.3%
DRV, ETV, ETR, RTV (Baseline, Month 12)	0 0%
DRV, LAM, RAL (Month 12)	1 1.3%
DRV, LAM, RAL (Baseline, Month 12)	0 0%
DRV, LAM, RAL, RTV (Month 12)	1 1.3%
DRV, LAM, RAL, RTV (Baseline, Month 12)	0 0%
DRV, LAM, TDF (Month 12)	1 1.3%
DRV, LAM, TDF (Baseline, Month 12)	1 1.3%
DRV, NVP, RAL, RTV (Month 12)	1 1.3%
DRV, NVP, RAL, RTV (Baseline, Month 12)	1 1.3%
DRV, RAL, RTV (Month 12)	4 5.1%
DRV, RAL, RTV (Baseline, Month 12)	4 5.1%
DRV, RTV (Month 12)	2 2.5%
DRV, RTV (Baseline, Month 12)	2 2.5%
DRV, RTV, TZV (Month 12)	1 1.3%
DRV, RTV, TZV (Baseline, Month 12)	1 1.3%
FTC/TDF (Month 12)	13 16.5%
FTC/TDF (Baseline, Month 12)	11 13.9%
FTC/TDF, Kaletra (Month 12)	2 2.5%
FTC/TDF, Kaletra (Baseline, Month 12)	1 1.3%
FTC/TDF, Kaletra, RAL (Month 12)	3 3.8%
FTC/TDF, Kaletra, RAL (Baseline, Month 12)	3 3.8%
FTC/TDF, Kaletra, SQV (Month 12)	1 1.3%
FTC/TDF, Kaletra, SQV (Baseline, Month 12)	1 1.3%
FTC/TDF, RAL (Month 12)	5 6.3%
FTC/TDF, RAL (Baseline, Month 12)	4 5.1%
FTC/TDF, RAL, SQV (Month 12)	1 1.3%
FTC/TDF, RAL, SQV (Baseline, Month 12)	1 1.3%
ETR, RAL, RTV (Month 12)	1 1.3%
ETR, RAL, RTV (Baseline, Month 12)	0 0%
Kaletra (Month 12)	2 2.5%
Kaletra (Baseline, Month 12)	2 2.5%
LAM, RAL, TDF, ZDV (Month 12)	1 1.3%
LAM, RAL, TDF, ZDV (Baseline, Month 12)	0 0%
RAL (Month 12)	2 2.5%
RAL (Baseline, Month 12)	2 2.5%
RAL, TDF (Month 12)	1 1.3%
RAL, TDF (Baseline, Month 12)	1 1.3%
RAL, ZDV W/LAM (Month 12)	1 1.3%
RAL, ZDV W/LAM (Baseline, Month 12)	1 1.3%
TDF, TZV (Month 12)	1 1.3%
TDF, TZV (Baseline, Month 12)	1 1.3%
TDF, ZDV (Month 12)	1 1.3%
TDF, ZDV (Baseline, Month 12)	1 1.3%

Adverse Events

Adverse Event Reporting 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.
Arm/Group Title	Maraviroc
Arm/Group Description	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.
All Cause Mortality
	Maraviroc
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Maraviroc
	Affected / at Risk (%)	# Events
Total	3/79 (3.8%)
Congenital, familial and genetic disorders
Ichthyosis	1/79 (1.3%)
Infections and infestations
Pneumonia	1/79 (1.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease	1/79 (1.3%)
Psychiatric disorders
Suicide attempt	1/79 (1.3%)
Respiratory, thoracic and mediastinal disorders
Respiratory arrest	1/79 (1.3%)
Other (Not Including Serious) Adverse Events
	Maraviroc
	Affected / at Risk (%)	# Events
Total	4/79 (5.1%)
Infections and infestations
Bronchitis	4/79 (5.1%)

Limitations/Caveats

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

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.