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
  Purpose

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 Intervention
HIV-1
Drug: maraviroc

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Non-Interventional Study Of Celsentri® In Treatment Experienced Patients Infected With CCR5 Tropic HIV-1

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3 [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
  • Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 6 [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
  • Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 12 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 3 [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
  • Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 6 [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
  • Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 12 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
  • Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).

  • Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).

  • Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Human Immunodeficiency Virus (HIV) Response [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Response was defined as a HIV-1 RNA count of less than 50 copies/mL.

  • Physician's Assessment of Efficacy [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Taking Concomitant Therapy [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    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).


Enrollment: 79
Study Start Date: July 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Non-Interventional
Drug: maraviroc
No intervention; any procedure at the discretion of the treating physician, in line with the SmPC
Other Name: Selzentry, Celsentri

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HIV-1 infected, therapy-experienced patients, CCR5-tropic virus,

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00850395

Sponsors and Collaborators
ViiV Healthcare
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
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

Keywords provided by ViiV Healthcare:
HIV-1
non-interventional
CCR-5 tropic virus
therapy experienced patients

ClinicalTrials.gov processed this record on April 22, 2014