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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00850395
First Posted: February 25, 2009
Last Update Posted: November 7, 2012
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.
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
  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 ]
  • Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 6 [ Time Frame: Baseline, Month 6 ]
  • Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 12 [ Time Frame: Baseline, Month 12 ]
  • Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 3 [ Time Frame: Baseline, Month 3 ]
  • Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 6 [ Time Frame: Baseline, Month 6 ]
  • Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 12 [ Time Frame: Baseline, Month 12 ]
  • Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 3 [ Time Frame: Month 3 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Response was defined as a HIV-1 RNA count of less than 50 copies/mL.

  • Physician's Assessment of Efficacy [ Time Frame: 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.

  • Number of Participants Taking Concomitant Therapy [ Time Frame: 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).


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00850395


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

Additional Information:
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00850395     History of Changes
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
Last Verified: November 2012

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

Additional relevant MeSH terms:
Maraviroc
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents