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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00850395
Recruitment Status : Completed
First Posted : February 25, 2009
Results First Posted : October 15, 2012
Last Update Posted : November 7, 2012
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Observational
Study Design Time Perspective: Prospective
Condition HIV-1
Intervention Drug: maraviroc
Enrollment 79
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Maraviroc
Hide 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
Reason Not Completed
Death             1
Adverse Event             1
Insufficient clinical response             3
Other             5
Arm/Group Title Maraviroc
Hide 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 Number of Baseline Participants 79
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 79 participants
44.1  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants
Female
12
  15.2%
Male
67
  84.8%
Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA)   [1] 
Mean (Standard Deviation)
Unit of measure:  Copies/milliliter (copies/mL)
Number Analyzed 79 participants
3.01  (1.599)
[1]
Measure Description: Number of participants evaluable for this measure=78.
Cluster of Differentiation 4 (CD4+) Cell Counts  
Mean (Standard Deviation)
Unit of measure:  Cells/microliter (cells/mcL)
Number Analyzed 79 participants
458.8  (250.14)
Number of Participants With Centers for Disease Control and Prevention (CDC) Classification   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 79 participants
Category A 31
Category B 21
Category C 27
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 79 participants
17.37  (14.026)
[1]
Measure Description: 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 Outcome
Title Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3
Hide Description [Not Specified]
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 75
Mean (Standard Deviation)
Unit of Measure: 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
Hide Description [Not Specified]
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 74
Mean (Standard Deviation)
Unit of Measure: 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
Hide Description [Not Specified]
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 79
Mean (Standard Deviation)
Unit of Measure: copies/mL
-0.95  (1.571)
4.Primary Outcome
Title Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 3
Hide Description [Not Specified]
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 75
Mean (Standard Deviation)
Unit of Measure: cells/mcL
74.31  (162.18)
5.Primary Outcome
Title Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 6
Hide Description [Not Specified]
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 75
Mean (Standard Deviation)
Unit of Measure: cells/mcL
91.88  (168.43)
6.Primary Outcome
Title Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 12
Hide Description [Not Specified]
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 79
Mean (Standard Deviation)
Unit of Measure: 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
Hide Description Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).
Time Frame Month 3
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 76
Measure Type: Number
Unit of Measure: participants
Category A 31
Category B 19
Category C 26
8.Primary Outcome
Title Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 6
Hide Description Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).
Time Frame Month 6
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 74
Measure Type: Number
Unit of Measure: participants
Category A 31
Category B 16
Category C 27
9.Primary Outcome
Title Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 12
Hide Description Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).
Time Frame Month 12
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 79
Measure Type: Number
Unit of Measure: participants
Category A 31
Category B 20
Category C 28
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 79
Mean (Standard Deviation)
Unit of Measure: units on a scale
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
Hide Description Response was defined as a HIV-1 RNA count of less than 50 copies/mL.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who received at least one dose (including partial doses) of study medication.
Arm/Group Title Maraviroc
Hide 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 Number of Participants Analyzed 79
Measure Type: Number
Unit of Measure: participants
51
12.Secondary Outcome
Title Physician's Assessment of Efficacy
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who received at least one dose (including partial doses) of study medication.
Arm/Group Title Maraviroc
Hide 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 Number of Participants Analyzed 79
Measure Type: Number
Unit of Measure: participants
Excellent 15
Very Good 42
Good 14
Fair 1
Poor 1
13.Secondary Outcome
Title Number of Participants Taking Concomitant Therapy
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who received at least one dose (including partial doses) of study medication.
Arm/Group Title Maraviroc
Hide 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 Number of Participants Analyzed 79
Measure Type: Number
Unit of Measure: participants
ABC, FTC/TDF (Month 12) 1
ABC, FTC/TDF (Baseline, Month 12) 1
ABC/LAM (Month 12) 2
ABC/LAM (Baseline, Month 12) 2
ABC/LAM, DRV, RAL (Month 12) 1
ABC/LAM, DRV, RAL (Baseline, Month 12) 0
ABC/LAM, RAL (Month 12) 2
ABC/LAM, RAL (Baseline, Month 12) 2
ABC/LAM, RAL, TDF (Month 12) 1
ABC/LAM, RAL, TDF (Baseline, Month 12) 1
ATV (Month 12) 1
ATV (Baseline, Month 12) 1
ATV, FTC/TDF (Month 12) 1
ATV, FTC/TDF (Baseline, Month 12) 1
ATV, FTC/TDF, RTV (Month 12) 1
ATV, FTC/TDF, RTV (Baseline, Month 12) 1
ATV, LAM, RAL, RTV (Month 12) 1
ATV, LAM, RAL, RTV (Baseline, Month 12) 0
ATV, RAL (Month 12) 2
ATV, RAL (Baseline, Month 12) 2
ATV, RAL, RTV (Month 12) 1
ATV, RAL, RTV (Baseline, Month 12) 1
ATV, RTV (Month 12) 1
ATV, RTV (Baseline, Month 12) 1
DRV, FTC/TDF (Month 12) 1
DRV, FTC/TDF (Baseline, Month 12) 1
DRV, FTC/TDF, ETR (Month 12) 1
DRV, FTC/TDF, ETR (Baseline, Month 12) 1
DRV, FTC/TDF, RTV (Month 12) 6
DRV, FTC/TDF, RTV (Baseline, Month 12) 5
DRV, ETV, ETR, RTV (Month 12) 1
DRV, ETV, ETR, RTV (Baseline, Month 12) 0
DRV, LAM, RAL (Month 12) 1
DRV, LAM, RAL (Baseline, Month 12) 0
DRV, LAM, RAL, RTV (Month 12) 1
DRV, LAM, RAL, RTV (Baseline, Month 12) 0
DRV, LAM, TDF (Month 12) 1
DRV, LAM, TDF (Baseline, Month 12) 1
DRV, NVP, RAL, RTV (Month 12) 1
DRV, NVP, RAL, RTV (Baseline, Month 12) 1
DRV, RAL, RTV (Month 12) 4
DRV, RAL, RTV (Baseline, Month 12) 4
DRV, RTV (Month 12) 2
DRV, RTV (Baseline, Month 12) 2
DRV, RTV, TZV (Month 12) 1
DRV, RTV, TZV (Baseline, Month 12) 1
FTC/TDF (Month 12) 13
FTC/TDF (Baseline, Month 12) 11
FTC/TDF, Kaletra (Month 12) 2
FTC/TDF, Kaletra (Baseline, Month 12) 1
FTC/TDF, Kaletra, RAL (Month 12) 3
FTC/TDF, Kaletra, RAL (Baseline, Month 12) 3
FTC/TDF, Kaletra, SQV (Month 12) 1
FTC/TDF, Kaletra, SQV (Baseline, Month 12) 1
FTC/TDF, RAL (Month 12) 5
FTC/TDF, RAL (Baseline, Month 12) 4
FTC/TDF, RAL, SQV (Month 12) 1
FTC/TDF, RAL, SQV (Baseline, Month 12) 1
ETR, RAL, RTV (Month 12) 1
ETR, RAL, RTV (Baseline, Month 12) 0
Kaletra (Month 12) 2
Kaletra (Baseline, Month 12) 2
LAM, RAL, TDF, ZDV (Month 12) 1
LAM, RAL, TDF, ZDV (Baseline, Month 12) 0
RAL (Month 12) 2
RAL (Baseline, Month 12) 2
RAL, TDF (Month 12) 1
RAL, TDF (Baseline, Month 12) 1
RAL, ZDV W/LAM (Month 12) 1
RAL, ZDV W/LAM (Baseline, Month 12) 1
TDF, TZV (Month 12) 1
TDF, TZV (Baseline, Month 12) 1
TDF, ZDV (Month 12) 1
TDF, ZDV (Baseline, Month 12) 1
Time Frame [Not Specified]
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
Hide 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 (%)
Total   --/-- 
Hide Serious Adverse Events
Maraviroc
Affected / at Risk (%)
Total   3/79 (3.80%) 
Congenital, familial and genetic disorders   
Ichthyosis * 1  1/79 (1.27%) 
Infections and infestations   
Pneumonia * 1  1/79 (1.27%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Hodgkin’s disease * 1  1/79 (1.27%) 
Psychiatric disorders   
Suicide attempt * 1  1/79 (1.27%) 
Respiratory, thoracic and mediastinal disorders   
Respiratory arrest * 1  1/79 (1.27%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Maraviroc
Affected / at Risk (%)
Total   4/79 (5.06%) 
Infections and infestations   
Bronchitis * 1  4/79 (5.06%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
Designation of outcomes as primary and secondary was based on study team input as study did not specify primary or secondary outcome measures.
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.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00850395    
Other Study ID Numbers: A4001070
CELTROP
First Submitted: February 23, 2009
First Posted: February 25, 2009
Results First Submitted: September 11, 2012
Results First Posted: October 15, 2012
Last Update Posted: November 7, 2012