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Completed

NCT Number: NCT00850395

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

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®.

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Key information

Conditions

HIV-1

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Maraviroc

Drug

No intervention; any procedure at the discretion of the treating physician, in line with the SmPC

Other names: Selzentry, Celsentri

Primary outcomes

  1. Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3

    Time frame: Baseline, Month 3

  2. Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 6

    Time frame: Baseline, Month 6

  3. Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 12

    Time frame: Baseline, Month 12

  4. Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 3

    Time frame: Baseline, Month 3

  5. Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 6

    Time frame: Baseline, Month 6

  6. Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 12

    Time frame: Baseline, Month 12

  7. 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).

  8. 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).

  9. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Collaborators

  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 25, 2009
Registry last updated
Nov 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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