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

February 23, 2009
November 5, 2012
July 2009
October 2011   (final data collection date for primary outcome measure)
  • 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).
  • CD4-count [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Reduction of viral load [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • CDC-classification [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00850395 on ClinicalTrials.gov Archive Site
  • 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).
Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Non-Interventional Study Of Celsentri® In Treatment Experienced Patients With CCR5-Tropic HIV-Infection
Non-Interventional Study Of Celsentri® In Treatment Experienced Patients Infected With CCR5 Tropic HIV-1

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®.

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

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

HIV-1
Drug: maraviroc
No intervention; any procedure at the discretion of the treating physician, in line with the SmPC
Other Name: Selzentry, Celsentri
1
Non-Interventional
Intervention: Drug: maraviroc
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
79
October 2011
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00850395
A4001070, CELTROP
No
ViiV Healthcare
ViiV Healthcare
Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
ViiV Healthcare
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP