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

HIV-1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00850395
• Other study ID #: A4001070
• Secondary ID: CELTROP
• Status: Completed
• Phase: N/A
• First received: February 23, 2009
• Last updated: November 5, 2012
• Start date: July 2009
• Est. completion date: October 2011

Study information

• Verified date: November 2012
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: BfArM
• Study type: Observational

Clinical Trial 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®.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV-1

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3		Baseline, Month 3	No
Primary	Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 6		Baseline, Month 6	No
Primary	Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 12		Baseline, Month 12	No
Primary	Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 3		Baseline, Month 3	No
Primary	Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 6		Baseline, Month 6	No
Primary	Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 12		Baseline, Month 12	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

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