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®.

Study Overview

• Status: Completed
• Conditions: HIV-1
• Intervention / Treatment: Drug: maraviroc

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 79

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3		Baseline, Month 3
Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 6		Baseline, Month 6
Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 12		Baseline, Month 12
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 3		Baseline, Month 3
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 6		Baseline, Month 6
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 12		Baseline, Month 12
Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 3	Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).	Month 3
Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 6	Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).	Month 6
Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 12	Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).	Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Overall Score at Months 6 and 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.	Baseline, Months 6, 12
Number of Participants With Human Immunodeficiency Virus (HIV) Response	Response was defined as a HIV-1 RNA count of less than 50 copies/mL.	Month 12
Physician's Assessment of Efficacy	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.	Month 12
Number of Participants Taking Concomitant Therapy	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).	Baseline, Month 12

Collaborators and Investigators

• Sponsor: ViiV Healthcare
• Collaborators: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (ACTUAL): October 1, 2011
• Study Completion (ACTUAL): October 1, 2011

Study Registration Dates

• First Submitted: February 23, 2009
• First Submitted That Met QC Criteria: February 24, 2009
• First Posted (ESTIMATE): February 25, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): November 7, 2012
• Last Update Submitted That Met QC Criteria: November 5, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: HIV-1; non-interventional; CCR-5 tropic virus; therapy experienced patients
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; HIV Fusion Inhibitors; Viral Fusion Protein Inhibitors; CCR5 Receptor Antagonists; Maraviroc
• Other Study ID Numbers: A4001070; CELTROP