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

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

Official Title
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Non-Interventional Study Of Celsentri® In Treatment Experienced Patients Infected With CCR5 Tropic HIV-1

Conditions
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HIV-1

Intervention / Treatment
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* Drug: maraviroc


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-1 infection. CCR-5 tropic virus. Therapy experienced patient, Exclusion Criteria: X4 or D/M tropic virus. Therapy-naive patients.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Non-Interventional | Drug: maraviroc<br>* No intervention; any procedure at the discretion of the treating physician, in line with the SmPC<br>* Other names: Selzentry, Celsentri;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV-1, non-interventional, CCR-5 tropic virus, therapy experienced patients