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

Completed

• Conditions: HIV-1
• Interventions: Drug: maraviroc

• Registration Number: NCT00850395
• Lead Sponsor: ViiV Healthcare

Brief Summary

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®.

Detailed Description

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

Study Timeline

• Study First Submitted: 2009-02-23
• Study First Submitted QC: 2009-02-24
• Study First Posted: 2009-02-25
• Study Start: 2009-07
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Results First Submitted: 2012-09-11
• Results First Submitted QC: 2012-09-11
• Results First Posted: 2012-10-15
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-05
• Last Update Posted: 2012-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	maraviroc	Non-Interventional

Primary Outcome Measures

Name	Time	Method
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	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	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	Month 12	Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Overall Score at Months 6 and 12	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	Month 12	Response was defined as a HIV-1 RNA count of less than 50 copies/mL.
Physician's Assessment of Efficacy	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	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).